ABSORB B: ABSORB Clinical Investigation, Cohort B

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00856856
• Collaborator: (none)
• Enrollment: 101
• Locations: 12
• Arm: 1
• Duration (Months): 84
• Patients Per Site: 8.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and performance of the BVS Everolimus Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in two different major epicardial vessels.

Currently in development at Abbott Vascular. Not available for sale in the United States.

Condition or Disease	Intervention/Treatment	Phase
Coronary Disease; Coronary Artery Disease; Coronary Restenosis	Device: Bioabsorbable Everolimus Eluting Coronary Stent	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 101 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System (BVS EECSS) in the Treatment of Patients With de Novo Native Coronary Artery Lesions.
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Absorb stent Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)	Device: Bioabsorbable Everolimus Eluting Coronary Stent; Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease

Outcome Measures

Primary Outcome Measures

1. Hierarchical Major Adverse Cardiac Event (MACE) [30 days]

   Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

2. Hierarchical Major Adverse Cardiac Event (MACE) [1 year]

   Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

3. In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days [180 days]

   In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

4. In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year [1 year]

   In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up

Secondary Outcome Measures

1. Clinical Device Success (Per Lesion) [On day 0 (the day of procedure)]

   Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as device success only if the above criteria for clinical device are met.

2. Clinical Procedure Success (Per Patient) [On day 0 (the day of procedure)]

   Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia-driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure.

3. Hierarchical Major Adverse Cardiac Event (MACE) [180 days]

   Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

4. Hierarchical Major Adverse Cardiac Event (MACE) [270 days]

   Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

5. Hierarchical Major Adverse Cardiac Event (MACE) [2 years]

   Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

6. Hierarchical Major Adverse Cardiac Event (MACE) [3 years]

   Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

7. Hierarchical Major Adverse Cardiac Event (MACE) [4 years]

   Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

8. Hierarchical Major Adverse Cardiac Event (MACE) [5 years]

   Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).

9. Hierarchical Target Vessel Failure (TVF) [30 days]

   Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

10. Hierarchical Target Vessel Failure (TVF) [180 days]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

11. Hierarchical Target Vessel Failure (TVF) [270 days]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

12. Hierarchical Target Vessel Failure (TVF) [1 year]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

13. Hierarchical Target Vessel Failure (TVF) [2 years]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

14. Hierarchical Target Vessel Failure (TVF) [3 years]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

15. Hierarchical Target Vessel Failure (TVF) [4 years]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

16. Hierarchical Target Vessel Failure (TVF) [5 years]

    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

17. Ischemia Driven Target Lesion Revascularization (ID-TLR) [30 days]

    ID-TLR is defined as the revascularization at the target lesion associated with any of the following: Positive functional ischemia study Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

18. Ischemia Driven Target Lesion Revascularization (ID-TLR) [180 days]

    ID-TLR is defined as the revascularization at the target lesion associated with any of the following: Positive functional ischemia study Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

19. Ischemia Driven Target Lesion Revascularization (ID-TLR) [270 days]

    ID-TLR is defined as the revascularization at the target lesion associated with any of the following: Positive functional ischemia study Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

20. Ischemia Driven Target Lesion Revascularization (ID-TLR) [1 year]

    ID-TLR is defined as the revascularization at the target lesion associated with any of the following: Positive functional ischemia study Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

21. Ischemia Driven Target Lesion Revascularization (ID-TLR) [2 years]

    ID-TLR is defined as the revascularization at the target lesion associated with any of the following: Positive functional ischemia study Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

22. Ischemia Driven Target Lesion Revascularization (ID-TLR) [3 years]

    ID-TLR is defined as the revascularization at the target lesion associated with any of the following: Positive functional ischemia study Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

23. Ischemia Driven Target Lesion Revascularization (ID-TLR) [4 years]

    ID-TLR is defined as the revascularization at the target lesion associated with any of the following: Positive functional ischemia study Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

24. Ischemia Driven Target Lesion Revascularization (ID-TLR) [5 years]

    ID-TLR is defined as the revascularization at the target lesion associated with any of the following: Positive functional ischemia study Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

25. Ischemia Driven Target Vessel Revascularization (ID-TVR) [30 days]

    ID-TVR is the revascularization in the target vessel associated with any of the following: Positive functional ischemia study Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

26. Ischemia Driven Target Vessel Revascularization (ID-TVR) [180 days]

    ID-TVR is the revascularization in the target vessel associated with any of the following: Positive functional ischemia study Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

27. Ischemia Driven Target Vessel Revascularization (ID-TVR) [270 days]

    ID-TVR is the revascularization in the target vessel associated with any of the following: Positive functional ischemia study Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

28. Ischemia Driven Target Vessel Revascularization (ID-TVR) [1 year]

    ID-TVR is the revascularization in the target vessel associated with any of the following: Positive functional ischemia study Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

29. Ischemia Driven Target Vessel Revascularization (ID-TVR) [2 years]

    ID-TVR is the revascularization in the target vessel associated with any of the following: Positive functional ischemia study Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

30. Ischemia Driven Target Vessel Revascularization (ID-TVR) [3 years]

    ID-TVR is the revascularization in the target vessel associated with any of the following: Positive functional ischemia study Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

31. Ischemia Driven Target Vessel Revascularization (ID-TVR) [4 years]

    ID-TVR is the revascularization in the target vessel associated with any of the following: Positive functional ischemia study Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

32. Ischemia Driven Target Vessel Revascularization (ID-TVR) [5 years]

    ID-TVR is the revascularization in the target vessel associated with any of the following: Positive functional ischemia study Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.

33. Cardiac Death [30 days]

    Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

34. Cardiac Death [1 year]

    Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

35. Cardiac Death [2 years]

    Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

36. Cardiac Death [3 years]

    Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

37. Cardiac Death [4 years]

    Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

38. Cardiac Death [5 years]

    Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

39. Myocardial Infarction [30 days]

    Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

40. Myocardial Infarction [1 year]

    Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

41. Myocardial Infarction [2 years]

    Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

42. Myocardial Infarction [3 years]

    Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

43. Myocardial Infarction [4 years]

    Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

44. Myocardial Infarction [5 years]

    Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

45. Scaffold Thrombosis [30 days]

    Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

46. Scaffold Thrombosis [1 year]

    Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

47. Scaffold Thrombosis [2 years]

    Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

48. Scaffold Thrombosis [3 years]

    Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

49. Scaffold Thrombosis [4 years]

    Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

50. Scaffold Thrombosis [5 years]

    Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.

51. In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 2 Years [2 years]

    In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

52. In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 3 Years [3 years]

    In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

53. In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 5 Years [5 years]

    In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.

54. Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 180 Days [180 days]

    Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).

55. Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 1 Year [1 year]

    Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).

56. Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 2 Years [2 years]

    Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).

57. Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 3 Years [3 years]

    Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).

58. Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 5 Years [5 years]

    Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).

59. Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 180 Days [180 days]

    Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).

60. Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 1 Year [1 year]

    Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).

61. Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 2 Years [2 years]

    Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).

62. Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 3 Years [3 years]

    Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).

63. Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 5 Years [5 years]

    Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).

64. In-scaffold Angiographic Binary Restenosis (ABR) [180 days]

    Percent of patients with a followup percent diameter stenosis of >=50% per QCA.

65. In-scaffold Angiographic Binary Restenosis (ABR) [1 year]

    Percent of patients with a followup percent diameter stenosis of >=50% per QCA.

66. In-scaffold Angiographic Binary Restenosis (ABR) [2 years]

    Percent of patients with a followup percent diameter stenosis of >=50% per QCA.

67. In-scaffold Angiographic Binary Restenosis (ABR) [3 years]

    Percent of patients with a followup percent diameter stenosis of >=50% per QCA.

68. In-scaffold Angiographic Binary Restenosis (ABR) [5 years]

    Percent of patients with a followup percent diameter stenosis of >=50% per QCA.

69. Persisting Dissection [180 days]

    Dissection at follow-up that was present post-procedure.

70. Persisting Dissection [1 year]

    Dissection at follow-up that was present post-procedure.

71. Persisting Dissection [2 years]

    Dissection at follow-up that was present post-procedure.

72. Persisting Dissection [3 years]

    Dissection at follow-up that was present post-procedure.

73. Persisting Dissection [5 years]

    Dissection at follow-up that was present post-procedure.

74. In-scaffold Percent Diameter Stenosis (%DS) [180 days]

    Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

75. In-scaffold Percent Diameter Stenosis (%DS) [1 year]

    Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

76. In-scaffold Percent Diameter Stenosis (%DS) [2 years]

    Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

77. In-scaffold Percent Diameter Stenosis (%DS) [3 years]

    Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

78. In-scaffold Percent Diameter Stenosis (%DS) [5 years]

    Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.

79. Aneurysm [180 days]

    An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.

80. Aneurysm [1 year]

    An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.

81. Aneurysm [2 years]

    An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.

82. Aneurysm [3 years]

    An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.

83. Aneurysm [5 years]

    An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.

84. Thrombus [180 days]

85. Thrombus [1 year]

86. Thrombus [2 years]

87. Thrombus [3 years]

88. Thrombus [5 years]

89. Vasomotion Analysis: In-scaffold Mean Luminal Diameter [5 years]

    Vasomotion function was assessed in reaction to nitrate administration.

90. Volume Obstruction (VO) [180 days]

    Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.

91. Volume Obstruction (VO) [1 year]

    Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.

92. Volume Obstruction (VO) [2 year]

    Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.

93. Volume Obstruction (VO) [3 year]

    Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.

94. Persisting Incomplete Apposition [180 days]

    Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

95. Persisting Incomplete Apposition [1 year]

    Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

96. Persisting Incomplete Apposition [2 year]

    Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

97. Persisting Incomplete Apposition [3 year]

    Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

98. Late Incomplete Apposition [180 days]

    Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

99. Late Incomplete Apposition [1 year]

    Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

100. Late Incomplete Apposition [2 year]

     Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

101. Late Incomplete Apposition [3 year]

     Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.

Other Outcome Measures

1. Mean Reference Area [1 year]

2. Mean Reference Area [2 years]

3. Mean Reference Area [3 years]

4. Mean Reference Area [5 years]

5. Mean Luminal Area [1 year]

6. Mean Luminal Area [2 years]

7. Mean Luminal Area [3 years]

8. Mean Luminal Area [5 years]

9. Minimum Luminal Area [1 year]

10. Minimum Luminal Area [2 years]

11. Minimum Luminal Area [3 years]

12. Minimum Luminal Area [5 years]

13. Mean Stent Area [1 year]

14. Mean Scaffold Area [2 years]

15. Mean Scaffold Area [3 years]

16. Minimum Stent Area [1 year]

17. Minimum Scaffold Area [2 year]

18. Minimum Scaffold Area [3 years]

19. Luminal Volume [1 year]

20. Luminal Volume [2 years]

21. Luminal Volume [3 years]

22. Luminal Volume [5 years]

23. Stent Volume [1 year]

24. Scaffold Volume [2 years]

25. Scaffold Volume [3 years]

26. Mean Luminal Diameter [1 year]

27. Mean Luminal Diameter [2 years]

28. Mean Luminal Diameter [3 years]

29. Mean Luminal Diameter [5 years]

    It is measured during QCA by the Angiographic Core Lab.

30. Minimum Luminal Diameter (MLD) [1 year]

    The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.

31. Minimum Luminal Diameter [2 years]

    The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.

32. Minimum Luminal Diameter [3 years]

    The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.

33. Minimum Luminal Diameter [5 years]

    The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.

34. Mean Stent Diameter [1 year]

35. Mean Scaffold Diameter [2 years]

36. Mean Scaffold Diameter [3 years]

37. Minimum Stent Diameter [1 year]

38. Minimum Scaffold Diameter [2 years]

39. Minimum Scaffold Diameter [3 years]

40. Strut Volume [1 year]

41. Strut Volume [2 years]

42. Strut Volume [3 years]

43. Number of Struts Per BVS [1 year]

44. Number of Struts Per BVS [2 years]

45. Number of Struts Per BVS [3 years]

46. Number of Struts Per BVS [5 years]

47. % of Covered Struts (150 µm) [1 year]

48. % of Acutely Covered Struts [2 years]

49. % of Acutely Covered Struts [3 years]

50. % of Uncovered Struts (150 µm) [1 year]

51. % of Uncovered Struts (150 µm) [2 years]

52. % of Uncovered Struts (150 µm) [3 years]

53. Number of Struts in Side Branch [1 year]

54. Number of Struts in Side Branch [2 years]

55. Number of Struts in Side Branch [3 years]

56. Number of Struts in Side Branch [5 years]

57. Tissue Coverage Area Classical [1 year]

58. Tissue Coverage Area BVS (Neointimal Area) [1 year]

59. Tissue Coverage Volume Classical [1 year]

60. Tissue Coverage Volume BVS [1 year]

61. Tissue Coverage Obstruction Volume Classical [1 year]

62. Tissue Coverage Obstruction Volume BVS [1 year]

63. Tissue Coverage Area Classical [2 years]

64. Tissue Coverage Area BVS (Neointimal Area) [2 years]

65. Tissue Coverage Volume Classical [2 years]

66. Tissue Coverage Volume BVS [2 years]

67. Tissue Coverage Obstruction Volume Classical [2 years]

68. Tissue Coverage Obstruction Volume BVS [2 years]

69. Tissue Coverage Area Classical [3 years]

70. Tissue Coverage Area BVS (Neointimal Area) [3 years]

71. Tissue Coverage Volume Classical [3 years]

72. Tissue Coverage Volume BVS [3 years]

73. Tissue Coverage Obstruction Volume Classical [3 years]

74. Tissue Coverage Obstruction Volume BVS [3 years]

75. Mean Flow Area [1 year]

76. Minimum Flow Area [1 year]

77. Mean Strut Core Area [1 year]

78. Percent (%) Lumen Area Stenosis [1 year]

79. Mean Flow Area [2 years]

80. Minimum Flow Area [2 years]

81. Mean Strut Core Area [2 years]

82. Percent (%) Lumen Area Stenosis [2 years]

83. Mean Flow Area [3 years]

84. Minimum Flow Area [3 years]

85. Mean Strut Core Area [3 years]

86. Percent (%) Lumen Area Stenosis [3 years]

87. Mean Flow Area [5 years]

88. Minimum Flow Area [5 years]

89. Percent (%) Lumen Area Stenosis [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

General inclusion criteria

1. Patient must be at least 18 years of age.

2. Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the BVS Everolimus Eluting CSS and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site.

3. Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia)

4. Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery

5. Patient must agree to undergo all clinical investigation plan-required follow-up visits, angiograms, intravascular ultrasound (IVUS), Palpography (optional), optical coherence tomography (OCT) (strongly recommended), multislice computed tomography (MSCT) (optional) and coronary vasomotion (optional)

6. Patient must agree not to participate in any other clinical investigation for a period of two years following the index procedure

Angiographic Inclusion Criteria

1. Target lesion(s) must be located in a native coronary artery with visually estimated nominal vessel diameter of 3.0 mm

2. Target lesion(s) must measure ≤ 14 mm in length by visual estimation

3. Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1

4. If two target lesions meet the inclusion criteria they must be in different major epicardial vessels left anterior descending artery (LAD) with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches

5. If two target lesion(s) are being treated, each of these lesions must meet all angiographic inclusion/exclusion criteria

6. Non-Clinical Investigation, percutaneous intervention for lesions in a non-target vessel is allowed if done ≥ 90 days prior to or if planned to be done 6 months after the index procedure

7. Non-Clinical Investigation percutaneous intervention for lesion in the target vessel is allowed if done > 6 months prior to or if planned to be done 6 months after the index procedure

General Exclusion Criteria

1. Patients has had a known diagnosis of acute myocardial infarction (AMI) within 3 days preceding the index procedure and creatine kinase (CK) and CK-MB have not returned within normal limits at the time of procedure

2. The patient is currently experiencing clinical symptoms consistent with AMI

3. Patient has current unstable arrhythmias

4. Patient has a known left ventricular ejection fraction (LVEF) < 30%

5. Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant

6. Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure

7. Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)

8. Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)

9. Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, everolimus, poly (L-lactide), poly (DL-lactide) or contrast sensitivity that cannot be adequately pre-medicated

10. Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel

11. Patient has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a white blood cell count of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)

12. Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis)

13. Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions

14. Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months

15. Patient has had a significant GI or urinary bleed within the past six months

16. Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion

17. Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)

18. Patient is already participating in another clinical investigation that has not yet reached its primary endpoint

19. Pregnant or nursing patients and those who plan pregnancy during the Clinical Investigation. (Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure and effective contraception must be used during participation in this Clinical Investigation)

20. Patient has received brachytherapy in any epicardial vessel (including side branches)

Angiographic Exclusion Criteria

1. Target lesion(s) meets any of the following criteria:

2. Aorto-ostial location (within 3 mm)

3. Left main location

4. Located within 2 mm of the origin of the LAD or LCX

5. Located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion, by visual estimation) arterial or saphenous vein graft

6. Lesion involving a bifurcation ≥ 2 mm in diameter and ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation

7. Total occlusion (TIMI flow 0), prior to wire crossing

8. Excessive tortuosity proximal to or within the lesion

9. Extreme angulation (≥ 90%) proximal to or within the lesion

10. Heavy calcification

11. Restenotic from previous intervention

12. The target vessel contains visible thrombus

13. Another clinically significant lesion is located in the same major epicardial vessel as the target lesion(s) (including side branches)

14. Patient has a high probability that a procedure other than pre-dilatation and stenting and (if necessary) post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Vincent's Hospital	Melbourne	Victoria	Australia	3065
2	Monash Heart	Melbourne		Australia
3	Onze-Lieve VrouweZiekenhuis	Aalst		Belgium
4	Skejby Sygehus	Aarhus		Denmark
5	Institut Hospitalier Jacques Cartier	Massy		France
6	Catharina ZH Eindhoven	Eindhoven		Netherlands
7	Erasmus Medical Center	Rotterdam		Netherlands
8	Maasstad Ziekenhuis	Rotterdam		Netherlands
9	Auckland City Hospital	Auckland		New Zealand
10	Christchurch Hospital	Christchurch		New Zealand
11	Jagiellonian University	Krakow		Poland
12	Inselspital Bern, Kardiologie	Bern		Switzerland	3010

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Patrick Serruys, MD, Erasmus Heart Center, Thorax Centrum
• Principal Investigator: John Ormiston, MD, Auckland City Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Absorb, cohort A

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00856856
• Other Study ID Numbers: 05-370 Cohort B
• First Posted: Mar 6, 2009
• Last Update Posted: Feb 7, 2019
• Last Verified: Jan 1, 2018

• Keywords provided by Abbott Medical Devices: Bioabsorbable; Coronary Stent; Everolimus; Drug eluting stents; Stents; Angioplasty; Coronary artery disease (CAD); Total coronary occlusion; Coronary artery restenosis; Stent thrombosis; Vascular disease; Myocardial ischemia; Coronary artery stenosis
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Coronary Restenosis; Everolimus

Study Results

Participant Flow

Recruitment Details	Total of 101 patients (intent to treat patient population [ITT]) were enrolled in the ABSORB Cohort B study at 12 clinical sites in Europe/Australia/New Zealand between March 19, 2009 and November 6, 2009. Only for assessing imaging outcomes at different follow-up periods, subjects were divided into Group 1 (n = 45) & Group 2 (n = 56).
Pre-assignment Detail	ITT population were assessed for all clinical endpoints. For imaging outcomes,Group 1 (n=45) patients were followed up at 180 days, 2 & 5 years; while Group 2 (n=56) patients at 1, 3 & 5 years. Therefore, data related to imaging outcomes are available only for Group 1 at 180 days, 2 & 5 years timeframe & only for Group 2 at 1, 3 & 5 years timeframe

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Period Title: Baseline
STARTED	101
COMPLETED	101
NOT COMPLETED	0
Period Title: Baseline
STARTED	101
COMPLETED	101
NOT COMPLETED	0
Period Title: Baseline
STARTED	101
COMPLETED	101
NOT COMPLETED	0
Period Title: Baseline
STARTED	101
COMPLETED	101
NOT COMPLETED	0
Period Title: Baseline
STARTED	101
COMPLETED	101
NOT COMPLETED	0
Period Title: Baseline
STARTED	101
COMPLETED	100
NOT COMPLETED	1
Period Title: Baseline
STARTED	100
COMPLETED	100
NOT COMPLETED	0
Period Title: Baseline
STARTED	100
COMPLETED	99
NOT COMPLETED	1
Period Title: Baseline
STARTED	100
COMPLETED	100
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Overall Participants	101
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	62.3
Sex: Female, Male (Count of Participants)
Female	28 27.7%
Male	73 72.3%
Region of Enrollment (participants) [Number]
New Zealand	14 13.9%
Netherlands	30 29.7%
Belgium	14 13.9%
Poland	13 12.9%
Denmark	12 11.9%
France	8 7.9%
Australia	4 4%
Switzerland	6 5.9%

Outcome Measures

1. Primary Outcome

Title	Hierarchical Major Adverse Cardiac Event (MACE)
Description	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	101
Number [percentage of participants]	2.0 2%

2. Primary Outcome

Title	Hierarchical Major Adverse Cardiac Event (MACE)
Description	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	101
Number [percentage of participants]	6.9 6.8%

3. Primary Outcome

Title	In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days
Description	In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

In Cohort B, Group 1. Intent-to-treat (ITT) population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS). Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. Cohort B patients were split into Group 1 having imaging follow-up at 180 days and 2 years and Group 2 having imaging follow-up at 1 year and 3 years.
Measure Participants	42
Measure Target lesions	42
Mean (Standard Deviation) [Millimeter]	0.19 (0.18)

4. Primary Outcome

Title	In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year
Description	In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

In Cohort B, Group 2. Intent-to-treat (ITT) population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS). Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. Cohort B patients were split into Group 1 having imaging follow-up at 180 days and 2 years and Group 2 having imaging follow-up at 1 year and 3 years.
Measure Participants	56
Measure Target lesions	57
Mean (Standard Deviation) [Millimeter]	0.27 (0.32)

5. Secondary Outcome

Title	Clinical Device Success (Per Lesion)
Description	Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as device success only if the above criteria for clinical device are met.
Time Frame	On day 0 (the day of procedure)

Outcome Measure Data

Analysis Population Description

Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	101
Measure Target lesions	102
Number [percentage of lesions]	100.0

6. Secondary Outcome

Title	Clinical Procedure Success (Per Patient)
Description	Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia-driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure.
Time Frame	On day 0 (the day of procedure)

Outcome Measure Data

Analysis Population Description

Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.

Arm/Group Title	ABSORB Stent
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	101
Number [percentage of participants]	98.0 97%

7. Secondary Outcome

Title	Hierarchical Major Adverse Cardiac Event (MACE)
Description	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	101
Number [percentage of participants]	5.0 5%

8. Secondary Outcome

Title	Hierarchical Major Adverse Cardiac Event (MACE)
Description	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Time Frame	270 days

Outcome Measure Data

Analysis Population Description

Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients. Intent-to-treat (ITT) population.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	101
Number [percentage of participants]	5.0 5%

9. Secondary Outcome

Title	Hierarchical Major Adverse Cardiac Event (MACE)
Description	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	100
Number [percentage of participants]	9.0 8.9%

10. Secondary Outcome

Title	Hierarchical Major Adverse Cardiac Event (MACE)
Description	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	100
Number [percentage of participants]	10.0 9.9%

11. Secondary Outcome

Title	Hierarchical Major Adverse Cardiac Event (MACE)
Description	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period. Intent-to-treat (ITT) population.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	99
Number [percentage of participants]	10.1 10%

12. Secondary Outcome

Title	Hierarchical Major Adverse Cardiac Event (MACE)
Description	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up. Intent-to-treat (ITT) population.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	100
Number [percentage of participants]	11.0 10.9%

13. Secondary Outcome

Title	Hierarchical Target Vessel Failure (TVF)
Description	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	101
Number [percentage of participants]	2.0 2%

14. Secondary Outcome

Title	Hierarchical Target Vessel Failure (TVF)
Description	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm/Group Title	ABSORB Stent
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	101
Number [Percentage of participants]	5.0 5%

15. Secondary Outcome

Title	Hierarchical Target Vessel Failure (TVF)
Description	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame	270 days

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm/Group Title	Absorb Stent
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	101
Number [Percentage of participants]	5.0 5%

16. Secondary Outcome

Title	Hierarchical Target Vessel Failure (TVF)
Description	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	101
Number [percentage of participants]	6.9 6.8%

17. Secondary Outcome

Title	Hierarchical Target Vessel Failure (TVF)
Description	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	100
Number [percentage of participants]	11.0 10.9%

18. Secondary Outcome

Title	Hierarchical Target Vessel Failure (TVF)
Description	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	100
Number [percentage of participants]	13.0 12.9%

19. Secondary Outcome

Title	Hierarchical Target Vessel Failure (TVF)
Description	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	99
Number [percentage of participants]	13.1 13%

20. Secondary Outcome

Title	Hierarchical Target Vessel Failure (TVF)
Description	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	100
Number [percentage of participants]	14.0 13.9%

21. Secondary Outcome

Title	Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description	ID-TLR is defined as the revascularization at the target lesion associated with any of the following: Positive functional ischemia study Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	101
Number [percentage of participants]	0 0%

22. Secondary Outcome

Title	Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description	ID-TLR is defined as the revascularization at the target lesion associated with any of the following: Positive functional ischemia study Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	101
Number [Percentage of participants]	2.0 2%

23. Secondary Outcome

Title	Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description	ID-TLR is defined as the revascularization at the target lesion associated with any of the following: Positive functional ischemia study Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	270 days

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	101
Number [Percentage of participants]	2.0 2%

24. Secondary Outcome

Title	Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description	ID-TLR is defined as the revascularization at the target lesion associated with any of the following: Positive functional ischemia study Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	101
Number [percentage of participants]	4.0 4%

25. Secondary Outcome

Title	Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description	ID-TLR is defined as the revascularization at the target lesion associated with any of the following: Positive functional ischemia study Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	100
Number [percentage of participants]	6.0 5.9%

26. Secondary Outcome

Title	Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description	ID-TLR is defined as the revascularization at the target lesion associated with any of the following: Positive functional ischemia study Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	100
Number [percentage of participants]	7.0 6.9%

27. Secondary Outcome

Title	Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description	ID-TLR is defined as the revascularization at the target lesion associated with any of the following: Positive functional ischemia study Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	99
Number [percentage of participants]	7.1 7%

28. Secondary Outcome

Title	Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description	ID-TLR is defined as the revascularization at the target lesion associated with any of the following: Positive functional ischemia study Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	100
Number [percentage of participants]	8.0 7.9%

29. Secondary Outcome

Title	Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description	ID-TVR is the revascularization in the target vessel associated with any of the following: Positive functional ischemia study Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	101
Number [Percentage of participants]	0.0 0%

30. Secondary Outcome

Title	Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description	ID-TVR is the revascularization in the target vessel associated with any of the following: Positive functional ischemia study Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	101
Number [Percentage of participants]	2.0 2%

31. Secondary Outcome

Title	Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description	ID-TVR is the revascularization in the target vessel associated with any of the following: Positive functional ischemia study Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	270 days

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	101
Number [Percentage of participants]	2.0 2%

32. Secondary Outcome

Title	Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description	ID-TVR is the revascularization in the target vessel associated with any of the following: Positive functional ischemia study Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	101
Number [Percentage of participants]	4.0 4%

33. Secondary Outcome

Title	Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description	ID-TVR is the revascularization in the target vessel associated with any of the following: Positive functional ischemia study Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	100
Number [Percentage of participants]	8.0 7.9%

34. Secondary Outcome

Title	Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description	ID-TVR is the revascularization in the target vessel associated with any of the following: Positive functional ischemia study Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	100
Number [Percentage of participants]	10.0 9.9%

35. Secondary Outcome

Title	Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description	ID-TVR is the revascularization in the target vessel associated with any of the following: Positive functional ischemia study Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patient (Group 1) lost to follow-up at 4-year follow-up period.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	99
Number [Percentage of participants]	10.0 9.9%

36. Secondary Outcome

Title	Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description	ID-TVR is the revascularization in the target vessel associated with any of the following: Positive functional ischemia study Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	100
Number [Percentage of participants]	11.0 10.9%

37. Secondary Outcome

Title	Cardiac Death
Description	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm/Group Title	ABSORB Stent
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	101
Number [percentage of participants]	0 0%

38. Secondary Outcome

Title	Cardiac Death
Description	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm/Group Title	ABSORB Stent
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	101
Number [percentage of participants]	0 0%

39. Secondary Outcome

Title	Cardiac Death
Description	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

Arm/Group Title	ABSORB Stent
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	100
Number [percentage of participants]	0 0%

40. Secondary Outcome

Title	Cardiac Death
Description	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

Arm/Group Title	ABSORB Stent
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	100
Number [percentage of participants]	0 0%

41. Secondary Outcome

Title	Cardiac Death
Description	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.

Arm/Group Title	ABSORB Stent
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	99
Number [percentage of participants]	0 0%

42. Secondary Outcome

Title	Cardiac Death
Description	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.

Arm/Group Title	ABSORB Stent
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	100
Number [percentage of participants]	0 0%

43. Secondary Outcome

Title	Myocardial Infarction
Description	Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm/Group Title	ABSORB Stent
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	101
Number [percentage of participants]	2.0 2%

44. Secondary Outcome

Title	Myocardial Infarction
Description	Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm/Group Title	ABSORB Stent
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	101
Number [percentage of participants]	3.0 3%

45. Secondary Outcome

Title	Myocardial Infarction
Description	Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

Arm/Group Title	ABSORB Stent
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	100
Number [percentage of participants]	3.0 3%

46. Secondary Outcome

Title	Myocardial Infarction
Description	Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

Arm/Group Title	ABSORB Stent
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	100
Number [percentage of participants]	3.0 3%

47. Secondary Outcome

Title	Myocardial Infarction
Description	Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.

Arm/Group Title	ABSORB Stent
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	99
Number [percentage of participants]	3.0 3%

48. Secondary Outcome

Title	Myocardial Infarction
Description	Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.

Arm/Group Title	ABSORB Stent
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	100
Number [percentage of participants]	3.0 3%

49. Secondary Outcome

Title	Scaffold Thrombosis
Description	Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm/Group Title	ABSORB Stent
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	101
Number [percentage of participants]	0 0%

50. Secondary Outcome

Title	Scaffold Thrombosis
Description	Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=45) and Group 2 (n=56) patients.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	101
Number [percentage of participants]	0 0%

51. Secondary Outcome

Title	Scaffold Thrombosis
Description	Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 2-year follow-up period.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	100
Number [percentage of participants]	0 0%

52. Secondary Outcome

Title	Scaffold Thrombosis
Description	Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient (Group 1) lost to follow-up at 3-year follow-up period.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	100
Number [percentage of participants]	0 0%

53. Secondary Outcome

Title	Scaffold Thrombosis
Description	Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=43) and Group 2 (n=56) patients. Two patients (Group 1) lost to follow-up at 4-year follow-up period.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	99
Number [percentage of participants]	0 0%

54. Secondary Outcome

Title	Scaffold Thrombosis
Description	Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following: Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Analysis population includes both Group 1 (n=44) and Group 2 (n=56) patients. One patient from Group 1 population had lost-to-follow-up. Where as,1 patient (Group 1) missed the 4-year follow up but returned for the 5-year follow up.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	100
Number [percentage of participants]	0 0%

55. Secondary Outcome

Title	In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 2 Years
Description	In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

ITT population. In Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS). Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. Cohort B patients were split into Group 1 having imaging follow-up at 180 days and 2 years and Group 2 having imaging follow-up at 1 year and 3 years.
Measure Participants	38
Measure Target lesions	38
Mean (Standard Deviation) [Millimeter]	0.27 (0.19)

56. Secondary Outcome

Title	In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 3 Years
Description	In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. In Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS). Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. Cohort B patients were split into Group 1 having imaging follow-up at 180 days and 2 years and Group 2 having imaging follow-up at 1 year and 3 years.
Measure Participants	50
Measure Target lesions	51
Mean (Standard Deviation) [Millimeter]	0.29 (0.43)

57. Secondary Outcome

Title	In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 5 Years
Description	In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS). Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. Cohort B patients were split into Group 1 having imaging follow-up at 180 days and 2 years and Group 2 having imaging follow-up at 1 year and 3 years.
Measure Participants	62
Measure Target lesions	63
Mean (Standard Deviation) [Millimeter]	0.26 (0.42)

58. Secondary Outcome

Title	Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 180 Days
Description	Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. In Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	42
Measure Target lesions	42
Mean (Standard Deviation) [Millimeter]	0.07 (0.27)

59. Secondary Outcome

Title	Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 1 Year
Description	Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. In Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	47
Measure Target lesions	48
Mean (Standard Deviation) [Millimeter]	0.12 (0.29)

60. Secondary Outcome

Title	Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 2 Years
Description	Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. In Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	38
Measure Target lesions	38
Mean (Standard Deviation) [Millimeter]	0.12 (0.36)

61. Secondary Outcome

Title	Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 3 Years
Description	Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. In Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	43
Measure Target lesions	44
Mean (Standard Deviation) [Millimeter]	0.14 (0.31)

62. Secondary Outcome

Title	Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 5 Years
Description	Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. In Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	57
Measure Target lesions	58
Mean (Standard Deviation) [Millimeter]	0.14 (0.43)

63. Secondary Outcome

Title	Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 180 Days
Description	Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	41
Measure Target lesions	41
Mean (Standard Deviation) [Millimeter]	0.07 (0.30)

64. Secondary Outcome

Title	Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 1 Year
Description	Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	54
Measure Target lesions	55
Mean (Standard Deviation) [Millimeter]	0.07 (0.27)

65. Secondary Outcome

Title	Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 2 Years
Description	Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	37
Measure Target lesions	37
Mean (Standard Deviation) [Millimeter]	0.04 (0.25)

66. Secondary Outcome

Title	Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 3 Years
Description	Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	48
Measure Target lesions	49
Mean (Standard Deviation) [Millimeter]	0.08 (0.37)

67. Secondary Outcome

Title	Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 5 Years
Description	Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	60
Measure Target lesions	61
Mean (Standard Deviation) [Millimeter]	0.11 (0.35)

68. Secondary Outcome

Title	In-scaffold Angiographic Binary Restenosis (ABR)
Description	Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	42
Measure Target lesions	42
Number [Percentage of participants]	0.0 0%

69. Secondary Outcome

Title	In-scaffold Angiographic Binary Restenosis (ABR)
Description	Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	56
Measure Target lesions	57
Number [Percentage of participants]	3.5 3.5%

70. Secondary Outcome

Title	In-scaffold Angiographic Binary Restenosis (ABR)
Description	Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	38
Measure Target lesions	38
Number [Percentage of participants]	0.0 0%

71. Secondary Outcome

Title	In-scaffold Angiographic Binary Restenosis (ABR)
Description	Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	50
Measure Target lesions	51
Number [Percentage of participants]	7.8 7.7%

72. Secondary Outcome

Title	In-scaffold Angiographic Binary Restenosis (ABR)
Description	Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	63
Measure Target lesions	64
Number [Percentage of participants]	7.8 7.7%

73. Secondary Outcome

Title	Persisting Dissection
Description	Dissection at follow-up that was present post-procedure.
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

ITT population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	42
Measure Target lesions	42
Number [Percentage of participants]	0.0 0%

74. Secondary Outcome

Title	Persisting Dissection
Description	Dissection at follow-up that was present post-procedure.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

ITT population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	56
Measure Target lesions	57
Number [Percentage of participants]	0.0 0%

75. Secondary Outcome

Title	Persisting Dissection
Description	Dissection at follow-up that was present post-procedure.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

ITT population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	38
Measure Target lesions	38
Number [Percentage of participants]	0.0 0%

76. Secondary Outcome

Title	Persisting Dissection
Description	Dissection at follow-up that was present post-procedure.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

ITT population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	47
Measure Target lesions	48
Number [Percentage of participants]	0.0 0%

77. Secondary Outcome

Title	Persisting Dissection
Description	Dissection at follow-up that was present post-procedure.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

ITT population. Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at 12 investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	47
Measure Target lesions	48
Number [Percentage of participants]	0.0 0%

78. Secondary Outcome

Title	In-scaffold Percent Diameter Stenosis (%DS)
Description	Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	42
Measure Target lesions	42
Mean (Standard Deviation) [percentage of diameter stenosis]	19.21 (7.62)

79. Secondary Outcome

Title	In-scaffold Percent Diameter Stenosis (%DS)
Description	Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	55
Measure Target lesions	56
Mean (Standard Deviation) [percentage of diameter stenosis]	21.35 (11.18)

80. Secondary Outcome

Title	In-scaffold Percent Diameter Stenosis (%DS)
Description	Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	38
Measure Target lesions	38
Mean (Standard Deviation) [percentage of diameter stenosis]	20.94 (7.63)

81. Secondary Outcome

Title	In-scaffold Percent Diameter Stenosis (%DS)
Description	Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	50
Measure Target lesions	51
Mean (Standard Deviation) [percentage of diameter stenosis]	23.16 (14.85)

82. Secondary Outcome

Title	In-scaffold Percent Diameter Stenosis (%DS)
Description	Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Cohort B, Group 1 and Group2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	63
Measure Target lesions	64
Mean (Standard Deviation) [percentage of diameter stenosis]	22.74 (13.94)

83. Secondary Outcome

Title	Aneurysm
Description	An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	42
Measure Target lesions	42
Number [Percentage of participants]	2.4 2.4%

84. Secondary Outcome

Title	Aneurysm
Description	An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	56
Measure Target lesions	57
Number [Percentage of participants]	0.0 0%

85. Secondary Outcome

Title	Aneurysm
Description	An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	38
Measure Target lesions	38
Number [Percentage of participants]	2.6 2.6%

86. Secondary Outcome

Title	Aneurysm
Description	An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	47
Measure Target lesions	48
Number [Percentage of participants]	2.08 2.1%

87. Secondary Outcome

Title	Aneurysm
Description	An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population.Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	47
Measure Target lesions	48
Number [Percentage of participants]	0.0 0%

88. Secondary Outcome

Title	Thrombus
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	42
Measure Target lesions	42
Number [Percentage of participants]	0.0 0%

89. Secondary Outcome

Title	Thrombus
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	56
Measure Target lesions	57
Number [Percentage of participants]	0.0 0%

90. Secondary Outcome

Title	Thrombus
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population.Cohort B, Group 1. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	38
Measure Target lesions	38
Number [Percentage of participants]	2.6 2.6%

91. Secondary Outcome

Title	Thrombus
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Cohort B, Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	47
Measure Target lesions	48
Number [Percentage of participants]	2.08 2.1%

92. Secondary Outcome

Title	Thrombus
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. Cohort B, Group 1 and Group 2. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	47
Measure Target lesions	48
Number [Percentage of participants]	0.0 0%

93. Secondary Outcome

Title	Vasomotion Analysis: In-scaffold Mean Luminal Diameter
Description	Vasomotion function was assessed in reaction to nitrate administration.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	52
Measure Target lesions	57
Pre-Nitro	2.49 (0.37)
Post-Nitro	2.56 (0.35)

94. Secondary Outcome

Title	Volume Obstruction (VO)
Description	Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

Cohort B, Group 1. ITT population; Intravascular ultrasound (IVUS) analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	40
Measure Target lesions	40
Mean (Standard Deviation) [percent of scaffold volume]	1.22 (1.99)

95. Secondary Outcome

Title	Volume Obstruction (VO)
Description	Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B, Group 2. ITT population; IVUS analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	55
Measure Target lesions	56
Mean (Standard Deviation) [percent of scaffold volume]	1.47 (3.08)

96. Secondary Outcome

Title	Volume Obstruction (VO)
Description	Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Time Frame	2 year

Outcome Measure Data

Analysis Population Description

Cohort B, Group 1. ITT population; IVUS analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	38
Measure Target lesions	38
Mean (Standard Deviation) [percent of scaffold volume]	3.33 (3.99)

97. Secondary Outcome

Title	Volume Obstruction (VO)
Description	Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

Cohort B, Group 2. ITT population; IVUS analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	45
Measure Target lesions	46
Mean (Standard Deviation) [percent of scaffold volume]	4.19 (6.43)

98. Secondary Outcome

Title	Persisting Incomplete Apposition
Description	Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

Cohort B, Group 1. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	43
Number [Percentage of participants]	2.3 2.3%

99. Secondary Outcome

Title	Persisting Incomplete Apposition
Description	Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B, Group 2. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	57
Number [Percentage of participants]	3.5 3.5%

100. Secondary Outcome

Title	Persisting Incomplete Apposition
Description	Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Time Frame	2 year

Outcome Measure Data

Analysis Population Description

Cohort B, Group 1. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	43
Number [Percentage of participants]	0.0 0%

101. Secondary Outcome

Title	Persisting Incomplete Apposition
Description	Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

Cohort B, Group 2. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	49
Number [Percentage of participants]	0.0 0%

102. Secondary Outcome

Title	Late Incomplete Apposition
Description	Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Time Frame	180 days

Outcome Measure Data

Analysis Population Description

Cohort B, Group 1. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	40
Number [Percentage of participants]	7.5 7.4%

103. Secondary Outcome

Title	Late Incomplete Apposition
Description	Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B, Group 2. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	56
Number [Percentage of participants]	3.6 3.6%

104. Secondary Outcome

Title	Late Incomplete Apposition
Description	Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Time Frame	2 year

Outcome Measure Data

Analysis Population Description

Cohort B, Group 1. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	38
Number [Percentage of participants]	2.6 2.6%

105. Secondary Outcome

Title	Late Incomplete Apposition
Description	Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

Cohort B, Group 2. Intent-to-treat (ITT) population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Measure Participants	43
Number [Percentage of participants]	7.0 6.9%

106. Other Pre-specified Outcome

Title	Mean Reference Area
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Optical coherence tomography (OCT) analysis,Cohort B Group 2, Intent-to-Treat Population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	30
Measure Target lesions	31
Mean (Standard Deviation) [mm^2]	6.34 (2.30)

107. Other Pre-specified Outcome

Title	Mean Reference Area
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

OCT analysis,Cohort B Group1 , Intent-to-Treat Population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	26
Measure Target lesions	27
Mean (Standard Deviation) [mm^2]	6.29 (2.13)

108. Other Pre-specified Outcome

Title	Mean Reference Area
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

OCT analysis,Cohort B Group 2, Intent-to-Treat Population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	39
Measure Target lesions	40
Mean (Standard Deviation) [mm^2]	6.24 (1.78)

109. Other Pre-specified Outcome

Title	Mean Reference Area
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

OCT analysis,Cohort B (Group 1 and Group 2), Intent-to-Treat Population. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	49
Measure Target lesions	50
Mean (Standard Deviation) [mm^2]	6.13 (1.96)

110. Other Pre-specified Outcome

Title	Mean Luminal Area
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	31
Measure Target lesions	31
Mean (Standard Deviation) [mm^2]	5.92 (1.71)

111. Other Pre-specified Outcome

Title	Mean Luminal Area
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [mm^2]	6.00 (1.76)

112. Other Pre-specified Outcome

Title	Mean Luminal Area
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [mm^2]	6.06 (1.70)

113. Other Pre-specified Outcome

Title	Mean Luminal Area
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Cohort B (Group 1 and Group 2), Intent-to-Treat (ITT) Population.OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	53
Measure Target lesions	54
Mean (Standard Deviation) [mm^2]	6.22 (1.84)

114. Other Pre-specified Outcome

Title	Minimum Luminal Area
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	31
Measure Target lesions	31
Mean (Standard Deviation) [mm^2]	4.29 (1.39)

115. Other Pre-specified Outcome

Title	Minimum Luminal Area
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [mm^2]	4.29 (1.48)

116. Other Pre-specified Outcome

Title	Minimum Luminal Area
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [mm^2]	4.45 (1.55)

117. Other Pre-specified Outcome

Title	Minimum Luminal Area
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	53
Measure Target lesions	54
Mean (Standard Deviation) [mm^2]	4.15 (1.69)

118. Other Pre-specified Outcome

Title	Mean Stent Area
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	31
Measure Target lesions	31
Mean (Standard Deviation) [mm^2]	7.42 (1.22)

119. Other Pre-specified Outcome

Title	Mean Scaffold Area
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [mm^2]	8.14 (1.88)

120. Other Pre-specified Outcome

Title	Mean Scaffold Area
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [mm^2]	8.50 (1.93)

121. Other Pre-specified Outcome

Title	Minimum Stent Area
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	31
Measure Target lesions	31
Mean (Standard Deviation) [mm^2]	5.96 (1.14)

122. Other Pre-specified Outcome

Title	Minimum Scaffold Area
Time Frame	2 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [mm^2]	6.33 (1.45)

123. Other Pre-specified Outcome

Title	Minimum Scaffold Area
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [mm^2]	6.66 (1.67)

124. Other Pre-specified Outcome

Title	Luminal Volume
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	31
Measure Target lesions	31
Mean (Standard Deviation) [mm^3]	106.33 (31.42)

125. Other Pre-specified Outcome

Title	Luminal Volume
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [mm^3]	107.66 (34.79)

126. Other Pre-specified Outcome

Title	Luminal Volume
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [mm^3]	103.31 (30.86)

127. Other Pre-specified Outcome

Title	Luminal Volume
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1 and Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	53
Measure Target lesions	54
Mean (Standard Deviation) [mm^3]	106.36 (32.72)

128. Other Pre-specified Outcome

Title	Stent Volume
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	31
Measure Target lesions	31
Mean (Standard Deviation) [mm^3]	132.90 (21.64)

129. Other Pre-specified Outcome

Title	Scaffold Volume
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [mm^3]	145.78 (38.28)

130. Other Pre-specified Outcome

Title	Scaffold Volume
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [mm^3]	145.07 (36.69)

131. Other Pre-specified Outcome

Title	Mean Luminal Diameter
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	31
Measure Target lesions	31
Mean (Standard Deviation) [mm]	2.71 (0.39)

132. Other Pre-specified Outcome

Title	Mean Luminal Diameter
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [mm]	2.72 (0.42)

133. Other Pre-specified Outcome

Title	Mean Luminal Diameter
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [mm]	2.74 (0.39)

134. Other Pre-specified Outcome

Title	Mean Luminal Diameter
Description	It is measured during QCA by the Angiographic Core Lab.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	53
Measure Target lesions	54
Mean (Standard Deviation) [mm]	2.77 (0.42)

135. Other Pre-specified Outcome

Title	Minimum Luminal Diameter (MLD)
Description	The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	31
Measure Target lesions	31
Mean (Standard Deviation) [mm]	2.30 (0.42)

136. Other Pre-specified Outcome

Title	Minimum Luminal Diameter
Description	The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1 , Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [mm]	2.30 (0.40)

137. Other Pre-specified Outcome

Title	Minimum Luminal Diameter
Description	The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [mm]	2.34 (0.46)

138. Other Pre-specified Outcome

Title	Minimum Luminal Diameter
Description	The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in scaffold or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Cohort B (Group1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	53
Measure Target lesions	54
Mean (Standard Deviation) [mm]	2.25 (0.49)

139. Other Pre-specified Outcome

Title	Mean Stent Diameter
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	31
Measure Target lesions	31
Mean (Standard Deviation) [mm]	3.06 (0.24)

140. Other Pre-specified Outcome

Title	Mean Scaffold Diameter
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [mm]	3.19 (0.38)

141. Other Pre-specified Outcome

Title	Mean Scaffold Diameter
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [mm]	3.26 (0.36)

142. Other Pre-specified Outcome

Title	Minimum Stent Diameter
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	31
Measure Target lesions	31
Mean (Standard Deviation) [mm]	2.74 (0.26)

143. Other Pre-specified Outcome

Title	Minimum Scaffold Diameter
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [mm]	2.82 (0.33)

144. Other Pre-specified Outcome

Title	Minimum Scaffold Diameter
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [mm]	2.89 (0.37)

145. Other Pre-specified Outcome

Title	Strut Volume
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	31
Measure Target lesions	31
Mean (Standard Deviation) [mm^3]	3.02 (0.66)

146. Other Pre-specified Outcome

Title	Strut Volume
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [mm^3]	2.61 (0.45)

147. Other Pre-specified Outcome

Title	Strut Volume
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [mm^3]	3.28 (0.83)

148. Other Pre-specified Outcome

Title	Number of Struts Per BVS
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	30
Measure Target lesions	31
Mean (Standard Deviation) [Number of Struts]	162.1 (31.9)

149. Other Pre-specified Outcome

Title	Number of Struts Per BVS
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [Number of Struts]	160.9 (27.9)

150. Other Pre-specified Outcome

Title	Number of Struts Per BVS
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [Number of Struts]	145.2 (32.3)

151. Other Pre-specified Outcome

Title	Number of Struts Per BVS
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	53
Measure Target lesions	54
Mean (Standard Deviation) [Number of Struts]	7.1 (29.1)

152. Other Pre-specified Outcome

Title	% of Covered Struts (150 µm)
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	31
Measure Target lesions	31
Mean (Standard Deviation) [Percent of Covered Struts]	96.86 (2.95)

153. Other Pre-specified Outcome

Title	% of Acutely Covered Struts
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [Percent of Covered Struts]	98.07 (3.27)

154. Other Pre-specified Outcome

Title	% of Acutely Covered Struts
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [Percent of Covered Struts]	97.90 (2.00)

155. Other Pre-specified Outcome

Title	% of Uncovered Struts (150 µm)
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	31
Measure Target lesions	31
Mean (Standard Deviation) [Percent of Uncovered Struts]	3.14 (2.95)

156. Other Pre-specified Outcome

Title	% of Uncovered Struts (150 µm)
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [Percent of Uncovered Struts]	1.93 (3.27)

157. Other Pre-specified Outcome

Title	% of Uncovered Struts (150 µm)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [Percent of Uncovered Struts]	2.10 (2.00)

158. Other Pre-specified Outcome

Title	Number of Struts in Side Branch
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	31
Measure Target lesions	31
Mean (Standard Deviation) [Number of struts]	0.1 (0.4)

159. Other Pre-specified Outcome

Title	Number of Struts in Side Branch
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [Number of struts]	0.2 (0.6)

160. Other Pre-specified Outcome

Title	Number of Struts in Side Branch
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [Number of struts]	0.2 (0.4)

161. Other Pre-specified Outcome

Title	Number of Struts in Side Branch
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	53
Measure Target lesions	54
Mean (Standard Deviation) [Number of struts]	0.0 (0.3)

162. Other Pre-specified Outcome

Title	Tissue Coverage Area Classical
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	31
Measure Target lesions	31
Mean (Standard Deviation) [mm^2]	1.54 (0.76)

163. Other Pre-specified Outcome

Title	Tissue Coverage Area BVS (Neointimal Area)
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	31
Mean (Standard Deviation) [mm^2]	1.38 (0.75)

164. Other Pre-specified Outcome

Title	Tissue Coverage Volume Classical
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	31
Measure Target lesions	31
Mean (Standard Deviation) [mm^3]	27.27 (13.16)

165. Other Pre-specified Outcome

Title	Tissue Coverage Volume BVS
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	31
Measure Target lesions	31
Mean (Standard Deviation) [mm^3]	24.40 (12.97)

166. Other Pre-specified Outcome

Title	Tissue Coverage Obstruction Volume Classical
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	31
Measure Target lesions	31
Mean (Standard Deviation) [Percent of Tissue Coverage Obstruction]	21.61 (11.77)

167. Other Pre-specified Outcome

Title	Tissue Coverage Obstruction Volume BVS
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	31
Measure Target lesions	31
Mean (Standard Deviation) [Percent of Tissue Coverage Obstruction]	19.40 (11.52)

168. Other Pre-specified Outcome

Title	Tissue Coverage Area Classical
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [mm^2]	2.13 (0.58)

169. Other Pre-specified Outcome

Title	Tissue Coverage Area BVS (Neointimal Area)
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [mm^2]	1.99 (0.58)

170. Other Pre-specified Outcome

Title	Tissue Coverage Volume Classical
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [mm^3]	38.12 (10.99)

171. Other Pre-specified Outcome

Title	Tissue Coverage Volume BVS
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [mm^3]	35.51 (10.87)

172. Other Pre-specified Outcome

Title	Tissue Coverage Obstruction Volume Classical
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [Percent of Tissue Coverage Obstruction]	27.10 (8.16)

173. Other Pre-specified Outcome

Title	Tissue Coverage Obstruction Volume BVS
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [Percent of Tissue Coverage Obstruction]	25.22 (7.91)

174. Other Pre-specified Outcome

Title	Tissue Coverage Area Classical
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [mm^2]	2.44 (0.61)

175. Other Pre-specified Outcome

Title	Tissue Coverage Area BVS (Neointimal Area)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [mm^2]	2.25 (0.60)

176. Other Pre-specified Outcome

Title	Tissue Coverage Volume Classical
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [mm^3]	41.76 (11.46)

177. Other Pre-specified Outcome

Title	Tissue Coverage Volume BVS
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [mm^3]	38.47 (11.20)

178. Other Pre-specified Outcome

Title	Tissue Coverage Obstruction Volume Classical
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [Percent of Tissue Coverage Obstruction]	29.36 (7.28)

179. Other Pre-specified Outcome

Title	Tissue Coverage Obstruction Volume BVS
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [Percent of Tissue Coverage Obstruction]	27.01 (7.10)

180. Other Pre-specified Outcome

Title	Mean Flow Area
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	31
Measure Target lesions	31
Mean (Standard Deviation) [mm^2]	5.90 (1.66)

181. Other Pre-specified Outcome

Title	Minimum Flow Area
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	31
Measure Target lesions	31
Mean (Standard Deviation) [mm^2]	4.28 (1.39)

182. Other Pre-specified Outcome

Title	Mean Strut Core Area
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	31
Measure Target lesions	31
Mean (Standard Deviation) [mm^2]	0.17 (0.05)

183. Other Pre-specified Outcome

Title	Percent (%) Lumen Area Stenosis
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	31
Measure Target lesions	31
Mean (Standard Deviation) [Percentage of Lumen Area Stenosis]	28.70 (12.05)

184. Other Pre-specified Outcome

Title	Mean Flow Area
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [mm^2]	6.00 (1.76)

185. Other Pre-specified Outcome

Title	Minimum Flow Area
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [mm^2]	4.29 (1.47)

186. Other Pre-specified Outcome

Title	Mean Strut Core Area
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [mm^2]	0.15 (0.02)

187. Other Pre-specified Outcome

Title	Percent (%) Lumen Area Stenosis
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 1, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	27
Measure Target lesions	28
Mean (Standard Deviation) [Percentage of Lumen Area Stenosis]	28.75 (10.58)

188. Other Pre-specified Outcome

Title	Mean Flow Area
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [mm^2]	6.06 (1.70)

189. Other Pre-specified Outcome

Title	Minimum Flow Area
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [mm^2]	4.45 (1.55)

190. Other Pre-specified Outcome

Title	Mean Strut Core Area
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [mm^2]	0.19 (0.04)

191. Other Pre-specified Outcome

Title	Percent (%) Lumen Area Stenosis
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

Cohort B Group 2, Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	45
Measure Target lesions	45
Mean (Standard Deviation) [Percentage of Lumen Area Stenosis]	28.01 (13.68)

192. Other Pre-specified Outcome

Title	Mean Flow Area
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	53
Measure Target lesions	54
Mean (Standard Deviation) [mm^2]	6.21 (1.83)

193. Other Pre-specified Outcome

Title	Minimum Flow Area
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	53
Measure Target lesions	54
Mean (Standard Deviation) [mm^2]	4.15 (1.69)

194. Other Pre-specified Outcome

Title	Percent (%) Lumen Area Stenosis
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Cohort B (Group 1 and Group 2), Intent-to-Treat Population. OCT analysis. The number of participants analyzed include subjects who had available follow-up data at that time frame.

Arm/Group Title	Absorb BVS
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease. Investigational devices available for the study were the Absorb BVS with a diameter of 3.0 mm and length of 18 mm. A total of 249 Absorb BVS were received at twelve investigational sites in the ABSORB Cohort B clinical study. Of the 249 devices received by the study sites, 102 were implanted in patients and 147 were returned to the sponsor.
Measure Participants	53
Measure Target lesions	54
Mean (Standard Deviation) [Percentage of Lumen Area Stenosis]	34.32 (16.21)

Adverse Events

Time Frame	5 years
Adverse Event Reporting Description	The data for adverse event reporting & clinical outcomes was collected from the full Cohort B (101 patients) up to 5 years (i.e. At Discharge,30 days,270 days,12 months,18 months,2,3,4 & 5 years).The subjects were only divided to Group 1 (n = 45; followed for 6 months, 2 & 5 years) and Group 2 (n = 56; followed for 1, 2 & 5 years) for analyzing imaging outcomes (Angiography, IVUS, Intravascular Ultrasound-virtual histology (IVUS-VH) and OCT imaging procedures) at different follow-up periods.
Arm/Group Title	ABSORB Stent
Arm/Group Description	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Bioabsorbable Everolimus Eluting Coronary Stent: Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
All Cause Mortality
	ABSORB Stent
	Affected / at Risk (%)	# Events
Total	0/101 (0%)
Serious Adverse Events
	ABSORB Stent
	Affected / at Risk (%)	# Events
Total	56/101 (55.4%)
Cardiac disorders
Angina pectoris	24/101 (23.8%)	40
Atrial fibrillation	4/101 (4%)	4
Atrial flutter	1/101 (1%)	1
Bradycardia	1/101 (1%)	1
Cardiac failure congestive	1/101 (1%)	1
Coronary artery stenosis	1/101 (1%)	1
Coronary artery thrombosis	1/101 (1%)	1
Myocardial infarction	3/101 (3%)	3
Myocardial ischaemia	6/101 (5.9%)	6
Palpitations	2/101 (2%)	2
Tachycardia	1/101 (1%)	1
Eye disorders
Cataract	1/101 (1%)	1
Gastrointestinal disorders
Abdominal pain upper	2/101 (2%)	2
Crohn's disease	1/101 (1%)	1
Gastric ulcer	1/101 (1%)	1
Gastrointestinal haemorrhage	1/101 (1%)	1
Tooth disorder	1/101 (1%)	1
General disorders
Adverse drug reaction	1/101 (1%)	1
Chest discomfort	1/101 (1%)	1
Chest pain	2/101 (2%)	2
Influenza like illness	1/101 (1%)	1
Malaise	1/101 (1%)	1
Non-cardiac chest pain	2/101 (2%)	11
Thrombosis in device	1/101 (1%)	1
Hepatobiliary disorders
Cholecystitis acute	1/101 (1%)	1
Infections and infestations
Bronchopneumonia	1/101 (1%)	1
Gangrene	1/101 (1%)	1
Infective exacerbation of chronic obstructive airways disease	1/101 (1%)	1
Lower respiratory tract infection	1/101 (1%)	1
Pneumonia	1/101 (1%)	1
Postoperative wound infection	1/101 (1%)	1
Injury, poisoning and procedural complications
Forearm fracture	1/101 (1%)	1
In-stent coronary artery restenosis	1/101 (1%)	1
Meniscus lesion	1/101 (1%)	1
Investigations
Cardiac stress test abnormal	1/101 (1%)	1
Metabolism and nutrition disorders
Dehydration	1/101 (1%)	1
Diabetes mellitus inadequate control	1/101 (1%)	1
Musculoskeletal and connective tissue disorders
Arthritis reactive	1/101 (1%)	1
Back pain	1/101 (1%)	1
Musculoskeletal discomfort	1/101 (1%)	1
Osteoarthritis	3/101 (3%)	3
Osteoporosis	1/101 (1%)	1
Pain in extremity	2/101 (2%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm	1/101 (1%)	1
Lung neoplasm malignant	1/101 (1%)	1
Malignant pleural effusion	1/101 (1%)	1
Mantle cell lymphoma	1/101 (1%)	1
Metastatic neoplasm	1/101 (1%)	1
Pancreatic carcinoma	1/101 (1%)	1
Squamous cell carcinoma	1/101 (1%)	1
Nervous system disorders
Carotid artery disease	1/101 (1%)	1
Haemorrhagic stroke	1/101 (1%)	1
Ischaemic stroke	1/101 (1%)	1
Presyncope	2/101 (2%)	2
Syncope	1/101 (1%)	1
Renal and urinary disorders
Nephrolithiasis	1/101 (1%)	1
Renal failure	1/101 (1%)	1
Urinary incontinence	1/101 (1%)	1
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/101 (1%)	1
Dyspnoea	2/101 (2%)	2
Respiratory failure	1/101 (1%)	1
Skin and subcutaneous tissue disorders
Diabetic foot	1/101 (1%)	1
Skin ulcer	2/101 (2%)	3
Vascular disorders
Haematoma	1/101 (1%)	1
Intermittent claudication	1/101 (1%)	2
Varicose vein	1/101 (1%)	1
Other (Not Including Serious) Adverse Events
	ABSORB Stent
	Affected / at Risk (%)	# Events
Total	58/101 (57.4%)
Cardiac disorders
Angina pectoris	44/101 (43.6%)	84
Atrial fibrillation	6/101 (5.9%)	10
Coronary artery dissection	10/101 (9.9%)	10
Myocardial ischaemia	6/101 (5.9%)	6
General disorders
Non-cardiac chest pain	18/101 (17.8%)	30
Musculoskeletal and connective tissue disorders
Pain in extremity	6/101 (5.9%)	6
Respiratory, thoracic and mediastinal disorders
Dyspnoea	9/101 (8.9%)	11
Vascular disorders
Haematoma	8/101 (7.9%)	8
Hypertension	9/101 (8.9%)	10

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.