SPIRIT SV: SPIRIT Small Vessel Registry

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00783796
• Collaborator: (none)
• Enrollment: 150
• Locations: 34
• Arm: 1
• Duration (Months): 62
• Patients Per Site: 4.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

To evaluate the safety and effectiveness of the 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in improving coronary luminal diameter in subjects with ischemic heart disease due to a maximum of two de novo native coronary artery lesions in small vessels, each in a different epicardial vessel.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Atherosclerosis; Myocardial Ischemia	Device: 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Spirit Small Vessel Registry (SPIRIT SV)
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 2.25mm XIENCE V® Patients receiving the 2.25 mm XIENCE V® stent	Device: 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System; Treatment of a maximum of two de novo native coronary artery lesions in small vessels.

Outcome Measures

Primary Outcome Measures

1. Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR). [1 year]

   This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.

2. Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR). [2 years]

   This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.

3. Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR). [3 years]

   This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.

Secondary Outcome Measures

1. Device Success (Per Lesion Basis, for Target Lesions Treated by 2.25 mm XIENCE V EECS With or Without Planned Overlap) [From start of index procedure to end of index procedure]

   Successful delivery and deployment of the first study stent intended to be implanted at the intended target lesion (or intended first and second investigational stents for overlapping stents), successful withdrawal of the stent delivery system, and attainment of final residual stenosis of <50%.

2. Procedural Success (Per Subject Basis, for ALL Target and Non-target Lesions) [From the start of index procedure to end of index procedure]

   Achievement of a final in-stent diameter stenosis of <50% using the study device, without the occurence of cardiac death, target vessel myocardial infarction per protocol definition, or repeat revascularization of the target lesion during the hospital stay up to 7 days.

3. In-Stent Late Loss [240 days]

   In-stent minimum lumen diameter (MLD) post-procedure minus in-stent MLD at angiographic follow-up.

4. In-segment Late Loss (LL) [240 Days]

   In-segment minimum lumen diameter (MLD) post-procedure minus in-segment MLD at angiographic follow-up.

5. Proximal Late Loss [240 days]

   Proximal minimum lumen diameter (MLD) post-procedure minus proximal MLD at angiographic follow-up (proximal defined as 5 mm of healthy tissue proximal to stent placement).

6. Distal Late Loss [240 days]

   Distal minimum lumen diameter (MLD) post-procedure minus distal MLD at angiographic follow-up (distal defined as 5 mm of healthy tissue distal to stent placement).

7. In-stent % Diameter Stenosis [240 days]

   Value calculated as 100*(1-MLD/RVD) where MLD is in-stent minimum lumen diameter and RVD is in-stent reference vessel diameter.

8. In-segment % Diameter Stenosis [240 days]

   Value calculated as 100*(1-MLD/RVD) where MLD is in-segment minimum lumen diameter and RVD is in-segment reference vessel diameter.

9. Proximal % Diameter Stenosis [240 days]

   Value calculated as 100*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue proximal to stent placement.

10. Distal % Diameter Stenosis [240 days]

    Value calculated as 100*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue distal to stent placement.

11. In-stent Angiographic Binary Restenosis (ABR) Rate [240 days]

    Percentage of patients with target lesions with ≥ 50% in-stent % diameter stenosis at angiographic follow-up.

12. In-segment Angiographic Binary Restenosis (ABR) Rate [240 days]

    Percentage of patients with target lesions with ≥ 50% in-segment % diameter stenosis at angiographic follow-up.

13. Proximal Angiographic Binary Restenosis (ABR) Rate [240 days]

    Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue proximal to stent placement at angiographic follow-up.

14. Distal Angiographic Binary Restenosis (ABR) Rate [240 days]

    Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue distal to stent placement at angiographic follow-up.

15. All Death (Cardiac, Vascular, Non-cardiovascular) [30 days]

    All death, including death from cardiac, vascular, and non-cardiovascular causes.

16. All Death (Cardiac, Vascular, Non-cardiovascular) [240 days]

    All death, including death from cardiac, vascular, and non-cardiovascular causes.

17. All Death (Cardiac, Vascular, Non-cardiovascular) [1 year]

    All death, including death from cardiac, vascular, and non-cardiovascular causes.

18. All Death (Cardiac, Vascular, Non-cardiovascular) [2 years]

    All death, including death from cardiac, vascular, and non-cardiovascular causes.

19. All Death (Cardiac, Vascular, Non-cardiovascular) [3 years]

    All death, including death from cardiac, vascular, and non-cardiovascular causes (per protocol).

20. Target Vessel MI - Q-wave and Non Q-wave (Per Protocol) [30 days]

    Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

21. Target Vessel MI - Q-wave and Non Q-wave (Per Protocol) [240 days]

    Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

22. Target Vessel MI - Q-wave and Non Q-wave (Per Protocol) [1 year]

    Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

23. Target Vessel MI - Q-wave and Non Q-wave (Per Protocol) [2 years]

    Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

24. Target Vessel MI - Q-wave and Non Q-wave (Per Protocol) [3 years]

    Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

25. Stent Thrombosis (ARC Defined) [0 to 1 day (Acute)]

    ARC defined: Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.

26. Stent Thrombosis (ARC Defined) [greater than 1 day to 30 days (Subacute)]

    ARC defined: Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.

27. Stent Thrombosis (ARC Defined) [31 days - 393 days (Late)]

    Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.

28. Stent Thrombosis (ARC Defined) [>1 year (Very late)]

    Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.

29. Stent Thrombosis (ARC Defined) [394 - 758 days (Very Late)]

    Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.

30. Stent Thrombosis (ARC Defined) [394 - 1123 days (Very Late)]

    Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.

31. Stent Thrombosis (ARC Defined) [Overall (0 - 393 days)]

    Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.

32. Stent Thrombosis (ARC Defined) [Overall (0 - 758 days)]

    Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.

33. Stent Thrombosis (ARC Defined) [Overall (0 - 1123 days)]

    Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.

34. Stent Thrombosis (Protocol Defined) [0 to 1 day (Acute)]

    Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.

35. Stent Thrombosis (Protocol Defined) [> 1 day to 30 days (Subacute)]

    Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.

36. Stent Thrombosis (Protocol Defined) [31 days to 393 days (Late)]

    Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.

37. Stent Thrombosis (Protocol Defined) [31 - 758 days (Late)]

    Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.

38. Stent Thrombosis (Protocol Defined) [31 - 1123 days (Late)]

    Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.

39. Stent Thrombosis (Protocol Defined) [Overall (0 - 393 days)]

    Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.

40. Stent Thrombosis (Protocol Defined) [Overall (0 - 758 days)]

    Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.

41. Stent Thrombosis (Protocol Defined) [Overall (0 - 1123 days)]

    Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.

42. All Death/ All MI/All Coronary Revascularization [30 days]

    This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.

43. All Death/ All MI/All Coronary Revascularization [240 days]

    This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.

44. All Death/ All MI/All Coronary Revascularization [1 year]

    This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.

45. All Death/ All MI/All Coronary Revascularization [2 years]

    This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.

46. All Death/ All MI/All Coronary Revascularization [3 years]

    This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.

47. Cardiac Death/ All MI /CI-TLR [30 days]

    This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).

48. Cardiac Death/ All MI /CI-TLR [240 days]

    This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).

49. Cardiac Death/ All MI /CI-TLR [1 year]

    This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).

50. Cardiac Death/ All MI /CI-TLR [2 years]

    This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).

51. Cardiac Death/ All MI /CI-TLR [3 years]

    This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).

52. Cardiac Death/MI [30 days]

    This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.

53. Cardiac Death/MI [240 days]

    This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.

54. Cardiac Death/MI [1 year]

    This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.

55. Cardiac Death/MI [2 years]

    This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.

56. Cardiac Death/MI [3 years]

    This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.

57. All Coronary Revascularization (TVR and Non-TVR) [30 days]

    Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.

58. All Coronary Revascularization (TVR and Non-TVR) [240 days]

    Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.

59. All Coronary Revascularization (TVR and Non-TVR) [1 year]

    Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.

60. All Coronary Revascularization (TVR and Non-TVR) [2 years]

    Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.

61. All Coronary Revascularization (TVR and Non-TVR) [3 years]

    Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel (per protocol).

62. All TVR (CI and Non-CI) [30 days]

    Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.

63. All TVR (CI and Non-CI) [240 days]

    Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.

64. All TVR (CI and Non-CI) [1 year]

    Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.

65. All TVR (CI and Non-CI) [2 years]

    Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.

66. All TVR (CI and Non-CI) [3 years]

    Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure (per protocol).

67. All TLR (CI and Non-CI) [30 days]

    Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.

68. All TLR (CI and Non-CI) [240 days]

    Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.

69. All TLR (CI and Non-CI) [1 year]

    Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.

70. All TLR (CI and Non-CI) [2 years]

    Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.

71. All TLR (CI and Non-CI) [3 years]

    Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated (per protocol).

72. Clinically Indicated Target Vessel Revascularization (TVR) [30 days]

    Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

73. Clinically Indicated Target Vessel Revascularization [240 days]

    Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

74. Clinically Indicated Target Vessel Revascularization [1 year]

    Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

75. Clinically Indicated Target Vessel Revascularization [2 years]

    Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

76. Clinically Indicated Target Vessel Revascularization [3 years]

    Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms (per protocol).

77. Clinically Indicated Target Lesion Revascularization (CI-TLR) [30 days]

    Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

78. Clinically Indicated Target Lesion Revascularization (CI-TLR) [240 days]

    Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

79. Clinically Indicated Target Lesion Revascularization (CI-TLR) [1 year]

    Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

80. Clinically Indicated Target Lesion Revascularization (CI-TLR) [2 years]

    Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.

81. Clinically Indicated Target Lesion Revascularization (CI-TLR) [3 years]

    Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms (per protocol).

82. Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol) [30 days]

    Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

83. Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol) [240 days]

    Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

84. Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol) [1 year]

    Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

85. Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol) [2 years]

    Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

86. Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol) [3 years]

    Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).

87. Target Vessel MI - Q-wave and Non Q-wave (Per ARC) [30 days]

    ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

88. Target Vessel MI - Q-wave and Non Q-wave (Per ARC) [240 days]

    ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

89. Target Vessel MI - Q-wave and Non Q-wave (Per ARC) [1 year]

    ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

90. Target Vessel MI - Q-wave and Non Q-wave (Per ARC) [2 years]

    ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

91. Target Vessel MI - Q-wave and Non Q-wave (Per ARC) [3 years]

    ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

92. Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC) [30 days]

    ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

93. Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC) [240 days]

    ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

94. Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC) [1 year]

    ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

95. Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC) [2 years]

    ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

96. Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC) [3 years]

    ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).

Eligibility Criteria

Criteria

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

General Inclusion Criteria

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

2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedure.

3. Subject 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. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.

5. Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.

Angiographic Inclusion Criteria

1. One target or two (two target or one target and one non-target) de novo lesion(s), each in a different epicardial vessel.

2. If there are two target lesions or one target and one non-target lesion, both lesions must satisfy the angiographic eligibility criteria.

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

4. The target lesion(s) or non-target lesion must be located in a native coronary artery with a reference vessel diameter by visual estimation of: Target Lesion: ≥ 2.25 mm to < 2.5 mm for treatment by the 2.25 mm XIENCE V® EECS.

Non-target Lesion: ≥2.5 mm to ≤4.25 mm for treatment by the commercial XIENCE V® EECS.

1. The target lesion(s) or non-target lesion must be located in a native coronary artery with a lesion length by visual estimation of ≤28 mm.

General Exclusion Criteria

1. Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB (creatine kinase myocardial-band isoenzyme) ≥2 times the upper limit of normal) and CK and CK-MB levels have not returned to within normal limits at the time of procedure.

2. The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.

3. Subject has current unstable cardiac arrhythmias associated with hemodynamic instability.

4. Subject has a known left ventricular ejection fraction (LVEF) < 30% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).

5. Subject has received coronary brachytherapy in any epicardial vessel.

6. Subject has received any organ transplant or is on a waiting list for any organ transplant.

7. Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure.

8. Subject is receiving or scheduled to receive planned radiation therapy to the chest or mediastinum.

9. Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.).

10. Subject is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).

11. Subjects who will require Low Molecular Weight Heparin (LMWH) post-procedure.

12. Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoropolymers or contrast sensitivity that cannot be adequately pre-medicated.

13. Elective surgery is planned within 12 months after the procedure that will require discontinuing either aspirin or clopidogrel.

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

15. Subject has known renal insufficiency (eg, serum creatinine level ≥ 2.5 mg/dL, or on dialysis).

16. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.

17. Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months.

18. Subject has had a significant gastro-intestinal or significant urinary bleed within the past six months.

19. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.

20. Subject 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 protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).

21. Subject is currently participating in another clinical study that has not yet completed its primary endpoint.

22. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

Angiographic Exclusion Criteria

1. Target lesion(s) or non-target lesion located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft.

2. Target lesion(s) or non-target lesion involving a bifurcation with a side branch ≥2 mm in diameter and/or ostial lesion > 40% stenosed by visual estimation or side branch requiring protection guide wire, or side branch requiring dilatation.

3. Total occlusion (TIMI flow 0), prior to crossing with the wire.

4. Another lesion requiring revascularization is located in the same epicardial vessel of either the target or non-target lesion.

5. Restenotic lesion.

6. Aorto-ostial lesion (within 3 mm of the aorta junction).

7. Left main location.

8. Lesion located within 2 mm of the origin of the LAD (left anterior descending) or LCX (left coronary artery)

9. Extreme angulation (≥90°) or excessive tortuosity (≥ two 45° angles) proximal to or within the target or non-target lesion.

10. Heavy calcification proximal to or within the target or non-target lesion(s).

11. Target or non-target vessel contains thrombus as indicated in the angiographic images.

12. Target lesion(s) or non-target lesion have a high probability that a procedure other than pre-dilatation and stenting will be required at the time of index procedure for treating the target and non-target vessel(s) (e.g. atherectomy, cutting balloon).

13. Target or non-target vessel(s) have previously been treated with percutaneous intervention (e.g. balloon angioplasty, stent, cutting balloon, atherectomy) < 9 months prior to index procedure.

14. A vessel not intended to be treated with a 2.25 mm XIENCE V® EECS or commercial sizes of XIENCE V® EECS that was previously treated with any type of PCI (percutaneous coronary intervention) < 90 days prior to the index procedure.

15. Additional clinically significant lesion(s) (e.g., %DS (diameter stenosis) ≥ 50%) is present in any vessel or side branch for which PCI may be required < 90 days after the index procedure.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scottsdale Healthcare	Scottsdale	Arizona	United States	85260
2	Arkansas Heart Hospital	Little Rock	Arkansas	United States	72211
3	Washington Hospital Center	Washington	District of Columbia	United States	20010
4	Morton Plant Hospital	Clearwater	Florida	United States	33756
5	Sacred Heart Hospital	Pensacola	Florida	United States	32504-8721
6	St. Anthony Hospital	Rockford	Illinois	United States	61107
7	St. John's Hospital / Prairie Education & Research Cooperative	Springfield	Illinois	United States	62769
8	Union Memorial Hospital	Baltimore	Maryland	United States	21218
9	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
10	St. Joseph Medical Center	Towson	Maryland	United States	21204
11	Baystate Medical Center	Springfield	Massachusetts	United States	01199
12	Northern Michigan Hospital	Petoskey	Michigan	United States	49770
13	St. Joseph Mercy Hospital	Ypsilanti	Michigan	United States	48197
14	St. Cloud Hospital	Saint Cloud	Minnesota	United States	56303
15	St. Patrick Hospital	Missoula	Montana	United States	59802
16	Cooper Health System	Camden	New Jersey	United States	08103
17	Gotham Cardiovascular Reasearch, PC. (St. Vincent's Medical Center-closing, pts moved)	New York	New York	United States	10011
18	Carolinas Medical Center	Charlotte	North Carolina	United States	28203
19	Presbyterian Hospital	Charlotte	North Carolina	United States	28204
20	WakeMed Hospital	Raleigh	North Carolina	United States	27610
21	Forsyth Medical Center	Winston-Salem	North Carolina	United States	27103
22	The Christ Hospital	Cincinnati	Ohio	United States	45219
23	University Hospitals Case Medical Center	Cleveland	Ohio	United States	44106
24	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
25	EMH Regional Medical Center	Elyria	Ohio	United States	44035
26	St. Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
27	Hillcrest Medical Center	Tulsa	Oklahoma	United States	74104
28	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
29	Sanford USD Medical Center	Sioux Falls	South Dakota	United States	57104
30	Baptist West Hospital	Knoxville	Tennessee	United States	37934
31	Northwest Texas Healthcare System	Amarillo	Texas	United States	79106
32	Mother Frances Hospital	Tyler	Texas	United States	75701
33	Overlake Hospital Medical Center	Bellevue	Washington	United States	98004
34	St. Joseph Hospital	Bellingham	Washington	United States	98225

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Marco A. Costa, MD, PhD, Case Western University Hospital, Cleveland, OH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00783796
• Other Study ID Numbers: 08-383
• First Posted: Nov 2, 2008
• Last Update Posted: May 8, 2019
• Last Verified: Apr 1, 2019

• Keywords provided by Abbott Medical Devices: Coronary artery disease; Atherosclerosis; Myocardial ischemia
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Atherosclerosis; Ischemia; Everolimus

Study Results

Participant Flow

Recruitment Details	150 subjects were recruited at 33 sites from the general interventional cardiology population. Dates of recruitment: 12/08/08 through 11/04/09.
Pre-assignment Detail	Subjects were screened for study eligibility by a member of the study team. Subjects meeting eligibility criteria were asked to sign an informed consent form. Pre-procedure angiography was used for final assessment of eligibility.

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
Period Title: Overall Study
STARTED	150
COMPLETED	144
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Overall Participants	150
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	85 56.7%
>=65 years	65 43.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.97 (10.59)
Sex/Gender, Customized (participants) [Number]
Female	57 38%
Male	92 61.3%
Region of Enrollment (participants) [Number]
United States	150 100%

Outcome Measures

1. Primary Outcome

Title	Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).
Description	This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	136
Number [Percentage of Participants]	8.1 5.4%

2. Primary Outcome

Title	Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).
Description	This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	132
Number [Percentage of Participants]	8.3 5.5%

3. Primary Outcome

Title	Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).
Description	This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	132
Number [Percentage of Participants]	12.1 8.1%

4. Secondary Outcome

Title	Device Success (Per Lesion Basis, for Target Lesions Treated by 2.25 mm XIENCE V EECS With or Without Planned Overlap)
Description	Successful delivery and deployment of the first study stent intended to be implanted at the intended target lesion (or intended first and second investigational stents for overlapping stents), successful withdrawal of the stent delivery system, and attainment of final residual stenosis of <50%.
Time Frame	From start of index procedure to end of index procedure

Outcome Measure Data

Analysis Population Description

Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects
Measure Participants	146
Measure Lesions	149
Number [Percentage of Lesions]	95.21

5. Secondary Outcome

Title	Procedural Success (Per Subject Basis, for ALL Target and Non-target Lesions)
Description	Achievement of a final in-stent diameter stenosis of <50% using the study device, without the occurence of cardiac death, target vessel myocardial infarction per protocol definition, or repeat revascularization of the target lesion during the hospital stay up to 7 days.
Time Frame	From the start of index procedure to end of index procedure

Outcome Measure Data

Analysis Population Description

Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects.

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects
Measure Participants	145
Number [Percentage of Participants]	97.93 65.3%

6. Secondary Outcome

Title	In-Stent Late Loss
Description	In-stent minimum lumen diameter (MLD) post-procedure minus in-stent MLD at angiographic follow-up.
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
Measure Participants	52
Mean (Standard Deviation) [Millimeters]	0.20 (0.40)

7. Secondary Outcome

Title	In-segment Late Loss (LL)
Description	In-segment minimum lumen diameter (MLD) post-procedure minus in-segment MLD at angiographic follow-up.
Time Frame	240 Days

Outcome Measure Data

Analysis Population Description

Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
Measure Participants	52
Mean (Standard Deviation) [Millimeters]	0.16 (0.41)

8. Secondary Outcome

Title	Proximal Late Loss
Description	Proximal minimum lumen diameter (MLD) post-procedure minus proximal MLD at angiographic follow-up (proximal defined as 5 mm of healthy tissue proximal to stent placement).
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
Measure Participants	34
Mean (Standard Deviation) [Millimeter]	0.21 (0.35)

9. Secondary Outcome

Title	Distal Late Loss
Description	Distal minimum lumen diameter (MLD) post-procedure minus distal MLD at angiographic follow-up (distal defined as 5 mm of healthy tissue distal to stent placement).
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
Measure Participants	45
Mean (Standard Deviation) [Millimeter]	0.00 (0.28)

10. Secondary Outcome

Title	In-stent % Diameter Stenosis
Description	Value calculated as 100*(1-MLD/RVD) where MLD is in-stent minimum lumen diameter and RVD is in-stent reference vessel diameter.
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
Measure Participants	52
Mean (Standard Deviation) [Percentage]	12.86 (19.58)

11. Secondary Outcome

Title	In-segment % Diameter Stenosis
Description	Value calculated as 100*(1-MLD/RVD) where MLD is in-segment minimum lumen diameter and RVD is in-segment reference vessel diameter.
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
Measure Participants	52
Mean (Standard Deviation) [Percentage]	20.85 (22.53)

12. Secondary Outcome

Title	Proximal % Diameter Stenosis
Description	Value calculated as 100*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue proximal to stent placement.
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
Measure Participants	37
Mean (Standard Deviation) [Percentage]	14.31 (13.16)

13. Secondary Outcome

Title	Distal % Diameter Stenosis
Description	Value calculated as 100*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue distal to stent placement.
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
Measure Participants	46
Mean (Standard Deviation) [Percentage]	10.4 (8.45)

14. Secondary Outcome

Title	In-stent Angiographic Binary Restenosis (ABR) Rate
Description	Percentage of patients with target lesions with ≥ 50% in-stent % diameter stenosis at angiographic follow-up.
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
Measure Participants	52
Number (95% Confidence Interval) [Percentage of Participants]	3.8 2.5%

15. Secondary Outcome

Title	In-segment Angiographic Binary Restenosis (ABR) Rate
Description	Percentage of patients with target lesions with ≥ 50% in-segment % diameter stenosis at angiographic follow-up.
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
Measure Participants	52
Number (95% Confidence Interval) [Percentage of Participants]	9.6 6.4%

16. Secondary Outcome

Title	Proximal Angiographic Binary Restenosis (ABR) Rate
Description	Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue proximal to stent placement at angiographic follow-up.
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
Measure Participants	37
Number (95% Confidence Interval) [Percentage of Participants]	2.7 1.8%

17. Secondary Outcome

Title	Distal Angiographic Binary Restenosis (ABR) Rate
Description	Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue distal to stent placement at angiographic follow-up.
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients in the Angiographic Cohort receiving the 2.25 mm XIENCE V Stent
Measure Participants	46
Number (95% Confidence Interval) [Percentage of Participants]	0.0 0%

18. Secondary Outcome

Title	All Death (Cardiac, Vascular, Non-cardiovascular)
Description	All death, including death from cardiac, vascular, and non-cardiovascular causes.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	144
Number (95% Confidence Interval) [Percentage of Participants]	0.7 0.5%

19. Secondary Outcome

Title	All Death (Cardiac, Vascular, Non-cardiovascular)
Description	All death, including death from cardiac, vascular, and non-cardiovascular causes.
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	139
Number (95% Confidence Interval) [Percentage of Participants]	1.4 0.9%

20. Secondary Outcome

Title	All Death (Cardiac, Vascular, Non-cardiovascular)
Description	All death, including death from cardiac, vascular, and non-cardiovascular causes.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	136
Number (95% Confidence Interval) [Percentage of Participants]	1.5 1%

21. Secondary Outcome

Title	All Death (Cardiac, Vascular, Non-cardiovascular)
Description	All death, including death from cardiac, vascular, and non-cardiovascular causes.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	133
Number (95% Confidence Interval) [percentage of participants]	1.5 1%

22. Secondary Outcome

Title	All Death (Cardiac, Vascular, Non-cardiovascular)
Description	All death, including death from cardiac, vascular, and non-cardiovascular causes (per protocol).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	132
Number (95% Confidence Interval) [percentage of participants]	3.8 2.5%

23. Secondary Outcome

Title	Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)
Description	Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	144
Number (95% Confidence Interval) [Percentage of Participants]	1.4 0.9%

24. Secondary Outcome

Title	Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)
Description	Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	139
Number (95% Confidence Interval) [Percentage of Participants]	1.4 0.9%

25. Secondary Outcome

Title	Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)
Description	Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	136
Number (95% Confidence Interval) [Percentage of Participants]	1.5 1%

26. Secondary Outcome

Title	Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)
Description	Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	133
Number (95% Confidence Interval) [percentage of participants]	1.5 1%

27. Secondary Outcome

Title	Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)
Description	Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	132
Number (95% Confidence Interval) [percentage of participants]	1.5 1%

28. Secondary Outcome

Title	Stent Thrombosis (ARC Defined)
Description	ARC defined: Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.
Time Frame	0 to 1 day (Acute)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	142
Number [Percentage of Participants]	0.0 0%

29. Secondary Outcome

Title	Stent Thrombosis (ARC Defined)
Description	ARC defined: Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.
Time Frame	greater than 1 day to 30 days (Subacute)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	140
Number [Percentage of Participants]	0.7 0.5%

30. Secondary Outcome

Title	Stent Thrombosis (ARC Defined)
Description	Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.
Time Frame	31 days - 393 days (Late)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	135
Number [Percentage of Participants]	1.5 1%

31. Secondary Outcome

Title	Stent Thrombosis (ARC Defined)
Description	Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.
Time Frame	>1 year (Very late)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	130
Number [Percentage of Participants]	0.0 0%

32. Secondary Outcome

Title	Stent Thrombosis (ARC Defined)
Description	Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.
Time Frame	394 - 758 days (Very Late)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	129
Number [Percentage of Participants]	0.0 0%

33. Secondary Outcome

Title	Stent Thrombosis (ARC Defined)
Description	Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.
Time Frame	394 - 1123 days (Very Late)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	128
Number [Percentage of Participants]	0.78 0.5%

34. Secondary Outcome

Title	Stent Thrombosis (ARC Defined)
Description	Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.
Time Frame	Overall (0 - 393 days)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	138
Number [Percentage of Participants]	2.17 1.4%

35. Secondary Outcome

Title	Stent Thrombosis (ARC Defined)
Description	Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.
Time Frame	Overall (0 - 758 days)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	131
Number [Percentage of Participants]	2.29 1.5%

36. Secondary Outcome

Title	Stent Thrombosis (ARC Defined)
Description	Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.
Time Frame	Overall (0 - 1123 days)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	130
Number [Percentage of Participants]	3.08 2.1%

37. Secondary Outcome

Title	Stent Thrombosis (Protocol Defined)
Description	Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.
Time Frame	0 to 1 day (Acute)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	142
Number [Percentage of Participants]	0.0 0%

38. Secondary Outcome

Title	Stent Thrombosis (Protocol Defined)
Description	Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.
Time Frame	> 1 day to 30 days (Subacute)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	140
Number [Percentage of Participants]	0.7 0.5%

39. Secondary Outcome

Title	Stent Thrombosis (Protocol Defined)
Description	Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.
Time Frame	31 days to 393 days (Late)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	135
Number [Percentage of Participants]	1.5 1%

40. Secondary Outcome

Title	Stent Thrombosis (Protocol Defined)
Description	Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.
Time Frame	31 - 758 days (Late)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	130
Number [Percentage of Participants]	1.5 1%

41. Secondary Outcome

Title	Stent Thrombosis (Protocol Defined)
Description	Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.
Time Frame	31 - 1123 days (Late)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	129
Number [Percentage of Participants]	2.3 1.5%

42. Secondary Outcome

Title	Stent Thrombosis (Protocol Defined)
Description	Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.
Time Frame	Overall (0 - 393 days)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	138
Number [percentage of participants]	2.2 1.5%

43. Secondary Outcome

Title	Stent Thrombosis (Protocol Defined)
Description	Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.
Time Frame	Overall (0 - 758 days)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	132
Number [percentage of participants]	2.27 1.5%

44. Secondary Outcome

Title	Stent Thrombosis (Protocol Defined)
Description	Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.
Time Frame	Overall (0 - 1123 days)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	130
Number [percentage of participants]	3.1 2.1%

45. Secondary Outcome

Title	All Death/ All MI/All Coronary Revascularization
Description	This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	144
Number (95% Confidence Interval) [Percentage of Participants]	3.5 2.3%

46. Secondary Outcome

Title	All Death/ All MI/All Coronary Revascularization
Description	This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	139
Number (95% Confidence Interval) [Percentage of Participants]	15.1 10.1%

47. Secondary Outcome

Title	All Death/ All MI/All Coronary Revascularization
Description	This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	136
Number (95% Confidence Interval) [Percentage of Participants]	16.9 11.3%

48. Secondary Outcome

Title	All Death/ All MI/All Coronary Revascularization
Description	This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	133
Number (95% Confidence Interval) [percentage of participants]	22.6 15.1%

49. Secondary Outcome

Title	All Death/ All MI/All Coronary Revascularization
Description	This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	132
Number (95% Confidence Interval) [percentage of participants]	26.5 17.7%

50. Secondary Outcome

Title	Cardiac Death/ All MI /CI-TLR
Description	This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	144
Number (95% Confidence Interval) [Percentage of Participants]	2.1 1.4%

51. Secondary Outcome

Title	Cardiac Death/ All MI /CI-TLR
Description	This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	139
Number (95% Confidence Interval) [Percentage of Participants]	7.2 4.8%

52. Secondary Outcome

Title	Cardiac Death/ All MI /CI-TLR
Description	This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	136
Number (95% Confidence Interval) [Percentage of Participants]	8.1 5.4%

53. Secondary Outcome

Title	Cardiac Death/ All MI /CI-TLR
Description	This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	133
Number (95% Confidence Interval) [percentage of participants]	8.3 5.5%

54. Secondary Outcome

Title	Cardiac Death/ All MI /CI-TLR
Description	This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	132
Number (95% Confidence Interval) [percentage of participants]	12.1 8.1%

55. Secondary Outcome

Title	Cardiac Death/MI
Description	This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	144
Number (95% Confidence Interval) [Percentage of Participants]	2.1 1.4%

56. Secondary Outcome

Title	Cardiac Death/MI
Description	This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	139
Number (95% Confidence Interval) [Percentage of Participants]	2.9 1.9%

57. Secondary Outcome

Title	Cardiac Death/MI
Description	This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	136
Number (95% Confidence Interval) [Percentage of Participants]	2.9 1.9%

58. Secondary Outcome

Title	Cardiac Death/MI
Description	This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	133
Number (95% Confidence Interval) [percentage of participants]	3.0 2%

59. Secondary Outcome

Title	Cardiac Death/MI
Description	This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	132
Number (95% Confidence Interval) [percentage of participants]	5.3 3.5%

60. Secondary Outcome

Title	All Coronary Revascularization (TVR and Non-TVR)
Description	Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	144
Number (95% Confidence Interval) [Percentage of Participants]	2.1 1.4%

61. Secondary Outcome

Title	All Coronary Revascularization (TVR and Non-TVR)
Description	Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	139
Number (95% Confidence Interval) [Percentage of Participants]	12.9 8.6%

62. Secondary Outcome

Title	All Coronary Revascularization (TVR and Non-TVR)
Description	Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	136
Number (95% Confidence Interval) [Percentage of Participants]	14.7 9.8%

63. Secondary Outcome

Title	All Coronary Revascularization (TVR and Non-TVR)
Description	Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	133
Number (95% Confidence Interval) [percentage of participants]	20.3 13.5%

64. Secondary Outcome

Title	All Coronary Revascularization (TVR and Non-TVR)
Description	Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel (per protocol).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	132
Number (95% Confidence Interval) [percentage of participants]	23.5 15.7%

65. Secondary Outcome

Title	All TVR (CI and Non-CI)
Description	Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	144
Number (95% Confidence Interval) [Percentage of Participants]	1.4 0.9%

66. Secondary Outcome

Title	All TVR (CI and Non-CI)
Description	Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	139
Number (95% Confidence Interval) [Percentage of Participants]	8.6 5.7%

67. Secondary Outcome

Title	All TVR (CI and Non-CI)
Description	Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	136
Number (95% Confidence Interval) [Percentage of Participants]	10.3 6.9%

68. Secondary Outcome

Title	All TVR (CI and Non-CI)
Description	Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	133
Number (95% Confidence Interval) [percentage of participants]	11.3 7.5%

69. Secondary Outcome

Title	All TVR (CI and Non-CI)
Description	Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure (per protocol).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	132
Number (95% Confidence Interval) [percentage of participants]	13.6 9.1%

70. Secondary Outcome

Title	All TLR (CI and Non-CI)
Description	Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	144
Number (95% Confidence Interval) [Percentage of Participants]	0.7 0.5%

71. Secondary Outcome

Title	All TLR (CI and Non-CI)
Description	Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	139
Number (95% Confidence Interval) [Percentage of Participants]	5.8 3.9%

72. Secondary Outcome

Title	All TLR (CI and Non-CI)
Description	Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	136
Number (95% Confidence Interval) [Percentage of Participants]	6.6 4.4%

73. Secondary Outcome

Title	All TLR (CI and Non-CI)
Description	Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	133
Number (95% Confidence Interval) [percentage of participants]	6.8 4.5%

74. Secondary Outcome

Title	All TLR (CI and Non-CI)
Description	Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated (per protocol).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	132
Number (95% Confidence Interval) [percentage of participants]	8.3 5.5%

75. Secondary Outcome

Title	Clinically Indicated Target Vessel Revascularization (TVR)
Description	Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	144
Number (95% Confidence Interval) [Percentage of Participants]	1.4 0.9%

76. Secondary Outcome

Title	Clinically Indicated Target Vessel Revascularization
Description	Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	139
Number (95% Confidence Interval) [Percentage of Participants]	7.2 4.8%

77. Secondary Outcome

Title	Clinically Indicated Target Vessel Revascularization
Description	Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	136
Number (95% Confidence Interval) [Percentage of Participants]	8.8 5.9%

78. Secondary Outcome

Title	Clinically Indicated Target Vessel Revascularization
Description	Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	133
Number (95% Confidence Interval) [percentage of participants]	9.8 6.5%

79. Secondary Outcome

Title	Clinically Indicated Target Vessel Revascularization
Description	Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms (per protocol).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	132
Number (95% Confidence Interval) [percentage of participants]	12.1 8.1%

80. Secondary Outcome

Title	Clinically Indicated Target Lesion Revascularization (CI-TLR)
Description	Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	144
Number (95% Confidence Interval) [Percentage of Participants]	0.0 0%

81. Secondary Outcome

Title	Clinically Indicated Target Lesion Revascularization (CI-TLR)
Description	Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	139
Number (95% Confidence Interval) [Percentage of Participants]	4.3 2.9%

82. Secondary Outcome

Title	Clinically Indicated Target Lesion Revascularization (CI-TLR)
Description	Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	136
Number (95% Confidence Interval) [Percentage of Participants]	5.1 3.4%

83. Secondary Outcome

Title	Clinically Indicated Target Lesion Revascularization (CI-TLR)
Description	Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	133
Number (95% Confidence Interval) [percentage of participants]	5.3 3.5%

84. Secondary Outcome

Title	Clinically Indicated Target Lesion Revascularization (CI-TLR)
Description	Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms (per protocol).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	132
Number (95% Confidence Interval) [percentage of participants]	6.8 4.5%

85. Secondary Outcome

Title	Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)
Description	Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	144
Number (95% Confidence Interval) [Percentage of Participants]	0.0 0%

86. Secondary Outcome

Title	Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)
Description	Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	139
Number (95% Confidence Interval) [Percentage of Participants]	0.0 0%

87. Secondary Outcome

Title	Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)
Description	Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	136
Number (95% Confidence Interval) [Percentage of Participants]	0.0 0%

88. Secondary Outcome

Title	Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)
Description	Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	133
Number (95% Confidence Interval) [percentage of participants]	0.0 0%

89. Secondary Outcome

Title	Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)
Description	Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	132
Number (95% Confidence Interval) [percentage of participants]	0.0 0%

90. Secondary Outcome

Title	Target Vessel MI - Q-wave and Non Q-wave (Per ARC)
Description	ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	144
Number (95% Confidence Interval) [Percentage of Participants]	6.3 4.2%

91. Secondary Outcome

Title	Target Vessel MI - Q-wave and Non Q-wave (Per ARC)
Description	ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	139
Number (95% Confidence Interval) [Percentage of Participants]	6.5 4.3%

92. Secondary Outcome

Title	Target Vessel MI - Q-wave and Non Q-wave (Per ARC)
Description	ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	136
Number (95% Confidence Interval) [Percentage of Participants]	6.6 4.4%

93. Secondary Outcome

Title	Target Vessel MI - Q-wave and Non Q-wave (Per ARC)
Description	ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	134
Number (95% Confidence Interval) [percentage of participants]	6.7 4.5%

94. Secondary Outcome

Title	Target Vessel MI - Q-wave and Non Q-wave (Per ARC)
Description	ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	133
Number (95% Confidence Interval) [percentage of participants]	7.5 5%

95. Secondary Outcome

Title	Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)
Description	ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	144
Number (95% Confidence Interval) [Percentage of participants]	0.0 0%

96. Secondary Outcome

Title	Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)
Description	ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).
Time Frame	240 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	139
Number (95% Confidence Interval) [Percentage of participants]	1.4 0.9%

97. Secondary Outcome

Title	Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)
Description	ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	136
Number (95% Confidence Interval) [Percentage of participants]	1.5 1%

98. Secondary Outcome

Title	Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)
Description	ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	134
Number (95% Confidence Interval) [percentage of participants]	1.5 1%

99. Secondary Outcome

Title	Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)
Description	ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).

Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
Measure Participants	133
Number (95% Confidence Interval) [percentage of participants]	4.5 3%

Adverse Events

Time Frame	0 to 1123 Day Serious Site-Reported, Un-Adjudicated Adverse Events Regardless of Relationship to the Device.
Adverse Event Reporting Description	The number of participants at risk does not always remain at 144 through the 3 years because 5 participants terminated sometime between 0-1123 days without any event and had no further information. These 5 patients were excluded from the denominator (this is a conservative approach) and at no time were event subjects excluded from the calculation.
Arm/Group Title	2.25mm XIENCE V®
Arm/Group Description	Patients receiving the 2.25 mm XIENCE V® stent
All Cause Mortality
	2.25mm XIENCE V®
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	2.25mm XIENCE V®
	Affected / at Risk (%)	# Events
Total	79/139 (56.8%)
Blood and lymphatic system disorders
Deficiency anaemia	1/139 (0.7%)	1
Haemorrhagic anaemia	1/139 (0.7%)	1
Thrombocytopenia	1/139 (0.7%)	1
Cardiac disorders
Acute coronary syndrome	1/139 (0.7%)	1
Acute myocardial infarction	5/139 (3.6%)	5
Angina pectoris	27/139 (19.4%)	33
Angina unstable	8/139 (5.8%)	8
Aortic valve stenosis	1/139 (0.7%)	1
Arteriosclerosis coronary artery	1/139 (0.7%)	1
Atrial fibrillation	6/139 (4.3%)	8
Atrial flutter	1/139 (0.7%)	1
Atrial thrombosis	1/139 (0.7%)	1
Atrioventricular block second degree	1/139 (0.7%)	1
Bradycardia	1/139 (0.7%)	1
Bundle branch block right	1/139 (0.7%)	1
Cardiac failure congestive	4/139 (2.9%)	5
Cardiac tamponade	1/139 (0.7%)	1
Cardiomyopathy	1/139 (0.7%)	1
Coronary artery disease	6/139 (4.3%)	7
Coronary artery dissection	1/139 (0.7%)	1
Coronary artery perforation	1/139 (0.7%)	1
Coronary artery stenosis	6/139 (4.3%)	6
Myocardial ischaemia	1/139 (0.7%)	1
Sick sinus syndrome	1/139 (0.7%)	1
Ventricular tachycardia	1/139 (0.7%)	1
Ear and labyrinth disorders
Vestibular disorder	1/139 (0.7%)	1
Eye disorders
Blindness	1/139 (0.7%)	1
Gastrointestinal disorders
Abdominal pain	1/139 (0.7%)	4
Dysphagia	1/139 (0.7%)	1
Nausea	1/139 (0.7%)	1
Pancreatitis	1/139 (0.7%)	1
Rectal haemorrhage	1/139 (0.7%)	1
Vomiting	2/139 (1.4%)	2
General disorders
Asthenia	1/139 (0.7%)	1
Catheter site haematoma	1/139 (0.7%)	1
Catheter site haemorrhage	1/139 (0.7%)	1
Non-cardiac chest pain	6/139 (4.3%)	11
Immune system disorders
Sarcoidosis	1/139 (0.7%)	1
Infections and infestations
Appendicitis	1/139 (0.7%)	1
Beta haemolytic streptococcal infection	1/139 (0.7%)	1
Bronchitis	1/139 (0.7%)	1
Lobar pneumonia	1/139 (0.7%)	1
Pneumonia	3/139 (2.2%)	3
Pyelonephritis	1/139 (0.7%)	1
Upper respiratory tract infection	1/139 (0.7%)	1
Urinary tract infection	2/139 (1.4%)	2
Wound infection staphylococcal	1/139 (0.7%)	1
Injury, poisoning and procedural complications
Ankle fracture	1/139 (0.7%)	1
In-stent coronary artery restenosis	5/139 (3.6%)	6
Mechanical complication of implant	1/139 (0.7%)	1
Traumatic brain injury	1/139 (0.7%)	1
Investigations
Cardiac enzymes increased	1/139 (0.7%)	1
Metabolism and nutrition disorders
Diabetic ketoacidosis	1/139 (0.7%)	1
Hyperglycaemia	1/139 (0.7%)	1
Hypoglycaemia	1/139 (0.7%)	1
Hyponatraemia	1/139 (0.7%)	1
Musculoskeletal and connective tissue disorders
Arthritis	1/139 (0.7%)	1
Back pain	1/139 (0.7%)	1
Costochondritis	1/139 (0.7%)	1
Lumbar spinal stenosis	1/139 (0.7%)	1
Osteoarthritis	3/139 (2.2%)	3
Rotator cuff syndrome	1/139 (0.7%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma	1/139 (0.7%)	1
Lung neoplasm	1/139 (0.7%)	1
Prostate cancer recurrent	1/139 (0.7%)	1
Thyroid neoplasm	1/139 (0.7%)	1
Nervous system disorders
Cerebellar infarction	1/139 (0.7%)	1
Cerebrovascular accident	2/139 (1.4%)	2
Convulsion	1/139 (0.7%)	1
Dementia Alzheimer's type	1/139 (0.7%)	1
Dizziness	1/139 (0.7%)	2
Encephalopathy	1/139 (0.7%)	1
Headache	1/139 (0.7%)	1
Hypertensive encephalopathy	1/139 (0.7%)	1
Intracranial aneurysm	1/139 (0.7%)	1
Lacunar infarction	1/139 (0.7%)	1
Migraine	2/139 (1.4%)	2
Post-traumatic headache	1/139 (0.7%)	1
Presyncope	2/139 (1.4%)	3
Syncope	2/139 (1.4%)	2
Transient ischaemic attack	4/139 (2.9%)	4
Vertigo	1/139 (0.7%)	1
Psychiatric disorders
Mental status changes	1/139 (0.7%)	1
Suicidal ideation	1/139 (0.7%)	2
Renal and urinary disorders
Calculus bladder	1/139 (0.7%)	1
Haematuria	1/139 (0.7%)	1
Renal failure	1/139 (0.7%)	1
Renal failure acute	1/139 (0.7%)	1
Renal mass	1/139 (0.7%)	1
Reproductive system and breast disorders
Benign prostatic hyperplasia	1/139 (0.7%)	1
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	2/139 (1.4%)	2
Dyspnoea	1/139 (0.7%)	1
Pleural effusion	1/139 (0.7%)	1
Pulmonary embolism	1/139 (0.7%)	1
Skin and subcutaneous tissue disorders
Rash	1/139 (0.7%)	1
Surgical and medical procedures
Cardiac ablation	1/139 (0.7%)	1
Surgery	1/139 (0.7%)	1
Vascular disorders
Aortic aneurysm	1/139 (0.7%)	1
Arteriosclerosis	1/139 (0.7%)	1
Carotid arteriosclerosis	1/139 (0.7%)	1
Carotid artery disease	2/139 (1.4%)	2
Carotid artery occlusion	2/139 (1.4%)	2
Deep vein thrombosis	2/139 (1.4%)	3
Gastric ulcer haemorrhage	1/139 (0.7%)	1
Hypertensive emergency	1/139 (0.7%)	1
Intestinal haemorrhage	1/139 (0.7%)	1
Renal artery stenosis	1/139 (0.7%)	1
Vascular pseudoaneurysm	1/139 (0.7%)	1
Other (Not Including Serious) Adverse Events
	2.25mm XIENCE V®
	Affected / at Risk (%)	# Events
Total	83/139 (59.7%)
Cardiac disorders
Angina pectoris	39/139 (28.1%)	50
Gastrointestinal disorders
Gastrooesophageal reflux disease	7/139 (5%)	7
General disorders
Fatigue	9/139 (6.5%)	10
Non-cardiac chest pain	25/139 (18%)	30
Musculoskeletal and connective tissue disorders
Back pain	17/139 (12.2%)	17
Myalgia	7/139 (5%)	8
Nervous system disorders
Dizziness	13/139 (9.4%)	15
Respiratory, thoracic and mediastinal disorders
Dyspnoea	14/139 (10.1%)	16
Vascular disorders
Contusion	7/139 (5%)	8
Hypertension	7/139 (5%)	7

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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.