XIENCE PRIME Japan Post-Marketing Surveillance (PMS)

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01721096
• Collaborator: (none)
• Enrollment: 536
• Location: 1
• Actual Duration (Months): 73
• Patients Per Site Per Month: 7.3

Study Details

Study Description

Brief Summary

The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and safety for reevaluation.

Condition or Disease	Intervention/Treatment	Phase
Angina; Coronary Occlusion; Coronary Artery Disease; Coronary Artery Stenosis; Myocardial Ischemia	Device: XIENCE PRIME - Long Length (LL); Device: XIENCE PRIME - Core Size

Detailed Description

The primary objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and safety for reevaluation by Pharmaceuticals and Medical Devices Agency (PMDA).

Study Design

• Study Type: Observational
• Actual Enrollment: 536 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: XIENCE PRIME Everolimus Eluting Coronary Stent Post Marketing Surveillance (PMS) in Japan
• Actual Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
XIENCE PRIME - Long Length (LL) Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length).There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted, and target lesion characteristics other than lesion lengths.	Device: XIENCE PRIME - Long Length (LL); Long Length
XIENCE PRIME - Core Size Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted, and target lesion characteristics other than lesion lengths.	Device: XIENCE PRIME - Core Size; Core Size

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Acute Stent Thrombosis (ST) [Time Frame: Acute (0-24 hours)]

   Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

2. Number of Participants With Subacute Stent Thrombosis (ST) [Subacute (>24 hours to 30 days)]

   Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).

3. Number of Participants With Late Stent Thrombosis (ST) [Late (>30 days to 1 year)]

   Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).

4. Total Number of Participants With Overall Stent Thrombosis [1 year post index procedure]

   Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).

Secondary Outcome Measures

1. Success Rate: Percentage of Participants With Implant Success Rate by Device [Participants will be followed for the duration of hospital stay, an average of 5 days]

   Successful delivery and deployment of the first study scaffold/stent the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 50% by quantitative coronary angiography (QCA).

2. Success Rate: Percentage of Participants With Procedural Success by Lesion [Participants will be followed for the duration of hospital stay, an average of 5 days]

   Achievement of final in-scaffold/stent residual stenosis of less than 50% by QCA with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (less than or equal to 7 days).

3. Success Rate: Percentage of Participants With Clinical Success by Patient (Per Patient Base) [Participants will be followed for the duration of hospital stay, an average of 5 days]

4. Number of Participants With Target Lesion Failure (TLF) [8 months post index procedure]

   Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR

5. Number of Participants With Target Lesion Failure (TLF) [1 year post index procedure]

   Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR

6. Number of Participants With Target Lesion Failure (TLF) [2 year post index procedure]

   Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR

7. Number of Participants With Target Lesion Failure (TLF) [3 years post index procedure]

   Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR

8. Number of Participants With Target Lesion Failure (TLF) [4 year post index procedure]

   Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR

9. Number of Participants With All Death/All MI/All Revascularization (DMR) [8 months post index procedure]

   DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

10. Number of Participants With All Death/All MI/All Revascularization (DMR) [1 year post index procedure]

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

11. Number of Participants With All Death/All MI/All Revascularization (DMR) [2 year post index procedure]

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

12. Number of Participants With All Death/All MI/All Revascularization (DMR) [3 year post index procedure]

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

13. Number of Participants With All Death/All MI/All Revascularization (DMR) [4 year post index procedure]

    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization

14. Number of Participants With Target Vessel Failure (TVF) [8 months post index procedure]

    Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).

15. Number of Participants With Target Vessel Failure (TVF) [1 year post index procedure]

    Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).

16. Number of Participants With Target Vessel Failure (TVF) [2 year post index procedure]

    Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).

17. Number of Participants With Target Vessel Failure (TVF) [3 year post index procedure]

    Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).

18. Number of Participants With Target Vessel Failure(TVF) [4 year post index procedure]

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

19. Number of Participants With Cardiac Death/All MI/CI-TLR (MACE) [8 months post index procedure]

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

20. Number of Participants With Cardiac Death/All MI/CI-TLR (MACE) [1 year post index procedure]

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

21. Number of Participants With Cardiac Death/All MI/CI-TLR (MACE) [2 year post index procedure]

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

22. Number of Participants With Cardiac Death/All MI/CI-TLR (MACE) [3 year post index procedure]

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

23. Number of Participants With Cardiac Death/All MI/CI-TLR (MACE) [4 year post index procedure]

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

24. Number of Participants With Death or Myocardial Infarction (MI) [8 months post index procedure]

    All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI

25. Number of Participants With Death or Myocardial Infarction (MI) [1 year post index procedure]

    All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI

26. Number of Participants With Death or Myocardial Infarction (MI) [2 year post index procedure]

    All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI

27. Number of Participants With Death or Myocardial Infarction (MI) [3 year post index procedure]

    All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI

28. Number of Participants With Death or Myocardial Infarction (MI) [4 year post index procedure]

    All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI

29. Number of Participants With Cardiac Death or Myocardial Infarction (MI) [8 months post index procedure]

    Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

30. Number of Participants With Cardiac Death or Myocardial Infarction (MI) [1 year post index procedure]

    Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

31. Number of Participants With Cardiac Death or Myocardial Infarction (MI) [2 year post index procedure]

    Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

32. Number of Participants With Cardiac Death or Myocardial Infarction (MI) [3 year post index procedure]

    Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

33. Number of Participants With Cardiac Death or Myocardial Infarction (MI) [4 year post index procedure]

    Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

34. Number of Participants With Cardiac Death or Target Vessel MI (TV-MI) [8 months post index procedure]

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

35. Number of Participants With Cardiac Death or Target Vessel MI (TV-MI) [1 year post index procedure]

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

36. Number of Participants With Cardiac Death or Target Vessel MI (TV-MI) [2 year post index procedure]

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

37. Number of Participants With Cardiac Death or Target Vessel MI (TV-MI) [3 year post index procedure]

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

38. Number of Participants With Cardiac Death or Target Vessel MI (TV-MI) [4 year post index procedure]

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

39. Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death) [8 months post index procedure]

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma

40. Number of of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death) [1 year post index procedure]

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma

41. Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death) [2 year post index procedure]

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma

42. Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death) [3 year post index procedure]

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma

43. Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death) [4 year post index procedure]

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma

44. Number of Participants With Myocardial Infarction (MI) [8 months post index procedure]

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

45. Number of Participants With Myocardial Infarction (MI) [1 year post index procedure]

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

46. Number of Participants With Myocardial Infarction (MI) [2 year post index procedure]

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

47. Number of Participants With Myocardial Infarction (MI) [3 year post index procedure]

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

48. Number of Participants With Myocardial Infarction (MI) [4 year post index procedure]

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

49. Number of Participants With Target Lesion Revascularization (TLR) [8 months post index procedure]

    Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR. Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.

50. Number of Participants With Target Lesion Revascularization (TLR) [1 year post index procedure]

    Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR. Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.

51. Number of Participants With Target Lesion Revascularization (TLR) [2 year post index procedure]

    Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR. Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.

52. Number of Participants With Target Lesion Revascularization (TLR) [3 year post index procedure]

    Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR. Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.

53. Number of Participants With Target Lesion Revascularization(TLR) [4 year post index procedure]

    Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR. Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.

54. Number of Participants With Non-Target Lesion Revascularization (Non-TLR) [8 months post index procedure]

    Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.

55. Number of Participants With Non-Target Lesion Revascularization (Non-TLR) [1 year post index procedure]

    Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.

56. Number of Participants With Non-Target Lesion Revascularization (Non-TLR) [2 year post index procedure]

    Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.

57. Number of Participants With Non-Target Lesion Revascularization (Non-TLR) [3 year post index procedure]

    Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.

58. Number of Participants With Non-Target Lesion Revascularization (Non-TLR) [4 year post index procedure]

    Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.

59. Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) [8 months post index procedure]

    Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)

60. Number of Participants With Target Vessel Revascularization (TLR or TVR ( Non-TLR)) [1 year post index procedure]

    Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)

61. Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) [2 year post index procedure]

    Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)

62. Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) [3 year post index procedure]

    Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)

63. Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) [4 year post index procedure]

    Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)

64. Number of Participants With Non-Target Vessel Revascularization (Non-TVR) [8 months post index procedure]

    Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.

65. Number of Participants With Non-Target Vessel Revascularization (Non-TVR) [1 year post index procedure]

    Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.

66. Number of Participants With Non-Target Vessel Revascularization (Non-TVR) [2 year post index procedure]

    Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.

67. Number of Participants With Non-Target Vessel Revascularization (Non-TVR) [3 year post index procedure]

    Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.

68. Number of Participants With Non-Target Vessel Revascularization (Non-TVR) [4 year post index procedure]

    Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.

69. Number of Participants With All Revascularization [8 months post index procedure]

    All revascularization includes ischemia driven and non-ischemia driven revascularization.

70. Number of Participants With All Revascularization [1 year post index procedure]

    All revascularization includes ischemia driven and non-ischemia driven revascularization.

71. Number of Participants With All Revascularization [2 year post index procedure]

    All revascularization includes ischemia driven and non-ischemia driven revascularization.

72. Number of Participants With All Revascularization [3 year post index procedure]

    All revascularization includes ischemia driven and non-ischemia driven revascularization.

73. Number of Participants With All Revascularization [4 year post index procedure]

    All revascularization includes ischemia driven and non-ischemia driven revascularization.

74. Number of Participants Experienced Bleeding [8 months post index procedure]

    Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding

75. Number of Participants Experienced Bleeding [1 year post index procedure]

    Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding

76. Number of Participants Experienced Bleeding [2 year post index procedure]

    Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding

77. Number of Participants Experienced Bleeding [3 year post index procedure]

    Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding

78. Number of Participants Experienced Bleeding [4 year post index procedure]

    Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding

79. Percent Diameter Stenosis (%DS) [Baseline]

    The value calculated as 100 * (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

80. Percent Diameter Stenosis (%DS) [Post procedure]

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

81. Percent Diameter Stenosis (%DS) [8 months post index procedure]

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

82. Acute Gain: In-stent, In-segment [8 months post index procedure]

    The difference between post- and pre-procedural MLD.

83. Net Gain: In-stent, In-segment [8 months post index procedure]

    Late procedural outcome is influenced by both the acute gain provided by the intervention (pre to post) and the subsequent late loss that occurs after the intervention (post to follow-up).The net gain is thus the sum of the offsetting effects of acute gain and late loss (net gain = acute gain - late loss).

84. Late Loss(LL): In-stent, In-segment, Proximal, and Distal [8 months post index procedure]

    Late loss is calculated as MLD post procedure - MLD at follow-up.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with ischemic heart disease who are eligible for treatment with XIENCE PRIME Everolimus Eluting Stent

• Patient provides Informed Consent Form

Exclusion Criteria:

• If it is known at the time of index procedure that the patient is not able to return for the 8-month follow-up visit for angiogram and for the 1-year clinical follow-up, then the patient should not be registered in the PMS.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abbott Vascular Japan Co., Ltd.	Tokyo		Japan	108-6304

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Study Chair: Ken Kozuma, MD, Teikyo University Hospital, Tokyo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01721096
• Other Study ID Numbers: 12-398
• First Posted: Nov 4, 2012
• Last Update Posted: Dec 20, 2019
• Last Verified: May 1, 2019

• Keywords provided by Abbott Medical Devices: Angioplasty; Drug eluting stents; Stents; Real world
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Stenosis; Coronary Occlusion; Ischemia

Study Results

Participant Flow

Recruitment Details	A total of 536 patients (213 in the Core Size (CS) arm and 323 in the Long Length (LL) arm) were recruited from the 25 sites between October 11, 2013 and June 30, 2013. All the patients except those terminated the surveillance have completed their follow-up at the end of the study.
Pre-assignment Detail	To date, out of 536 patients, 524 (320 in LL arm and 204 in CS arm) have terminated the surveillance before completing their follow-ups

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Period Title: Overall Study
STARTED	323	213
COMPLETED	3	9
NOT COMPLETED	320	204

Baseline Characteristics

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size	Total
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Total of all reporting groups
Overall Participants	323	213	536
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.6 (10.7)	69.1 (10.4)	68.8 (10.6)
Sex: Female, Male (Count of Participants)
Female	59 18.3%	46 21.6%	105 19.6%
Male	264 81.7%	167 78.4%	431 80.4%
Region of Enrollment (Count of Participants)
Japan	323 100%	213 100%	536 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Acute Stent Thrombosis (ST)
Description	Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).
Time Frame	Time Frame: Acute (0-24 hours)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Definite	0 0%	0 0%
Probable	0 0%	0 0%
Definite/Probable	0 0%	0 0%

2. Primary Outcome

Title	Number of Participants With Subacute Stent Thrombosis (ST)
Description	Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).
Time Frame	Subacute (>24 hours to 30 days)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	212
Definite	3 0.9%	0 0%
Probable	0 0%	0 0%
Definite/Probable	3 0.9%	0 0%

3. Primary Outcome

Title	Number of Participants With Late Stent Thrombosis (ST)
Description	Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).
Time Frame	Late (>30 days to 1 year)

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	212
Definite	0 0%	0 0%
Probable	0 0%	0 0%
Definite/Probable	0 0%	0 0%

4. Primary Outcome

Title	Total Number of Participants With Overall Stent Thrombosis
Description	Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).
Time Frame	1 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	212
Count of Participants [Participants]	3 0.9%	0 0%

5. Secondary Outcome

Title	Success Rate: Percentage of Participants With Implant Success Rate by Device
Description	Successful delivery and deployment of the first study scaffold/stent the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 50% by quantitative coronary angiography (QCA).
Time Frame	Participants will be followed for the duration of hospital stay, an average of 5 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up. Implant Success rate is calculated per stent base.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Measure Device used	522	259
Number (95% Confidence Interval) [percentage of devices]	99.8	99.6

6. Secondary Outcome

Title	Success Rate: Percentage of Participants With Procedural Success by Lesion
Description	Achievement of final in-scaffold/stent residual stenosis of less than 50% by QCA with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (less than or equal to 7 days).
Time Frame	Participants will be followed for the duration of hospital stay, an average of 5 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up. Procedural Success rate is calculated per lesion base.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Measure Lesions	402	241
Number (95% Confidence Interval) [Percentage of Lesions]	100	100

7. Secondary Outcome

Title	Success Rate: Percentage of Participants With Clinical Success by Patient (Per Patient Base)
Time Frame	Participants will be followed for the duration of hospital stay, an average of 5 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	212
Number (95% Confidence Interval) [percentage of participants]	100 31%	99.5 46.7%

8. Secondary Outcome

Title	Number of Participants With Target Lesion Failure (TLF)
Description	Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR
Time Frame	8 months post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	8 2.5%	2 0.9%

9. Secondary Outcome

Title	Number of Participants With Target Lesion Failure (TLF)
Description	Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR
Time Frame	1 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	17 5.3%	4 1.9%

10. Secondary Outcome

Title	Number of Participants With Target Lesion Failure (TLF)
Description	Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR
Time Frame	2 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	20 6.2%	7 3.3%

11. Secondary Outcome

Title	Number of Participants With Target Lesion Failure (TLF)
Description	Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR
Time Frame	3 years post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	23 7.1%	7 3.3%

12. Secondary Outcome

Title	Number of Participants With Target Lesion Failure (TLF)
Description	Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR
Time Frame	4 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	26 8%	7 3.3%

13. Secondary Outcome

Title	Number of Participants With All Death/All MI/All Revascularization (DMR)
Description	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time Frame	8 months post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	32 9.9%	14 6.6%

14. Secondary Outcome

Title	Number of Participants With All Death/All MI/All Revascularization (DMR)
Description	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time Frame	1 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	63 19.5%	29 13.6%

15. Secondary Outcome

Title	Number of Participants With All Death/All MI/All Revascularization (DMR)
Description	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time Frame	2 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	85 26.3%	41 19.2%

16. Secondary Outcome

Title	Number of Participants With All Death/All MI/All Revascularization (DMR)
Description	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time Frame	3 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	94 29.1%	46 21.6%

17. Secondary Outcome

Title	Number of Participants With All Death/All MI/All Revascularization (DMR)
Description	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time Frame	4 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	106 32.8%	55 25.8%

18. Secondary Outcome

Title	Number of Participants With Target Vessel Failure (TVF)
Description	Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).
Time Frame	8 months post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	11 3.4%	3 1.4%

19. Secondary Outcome

Title	Number of Participants With Target Vessel Failure (TVF)
Description	Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).
Time Frame	1 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	25 7.7%	8 3.8%

20. Secondary Outcome

Title	Number of Participants With Target Vessel Failure (TVF)
Description	Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).
Time Frame	2 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	31 9.6%	14 6.6%

21. Secondary Outcome

Title	Number of Participants With Target Vessel Failure (TVF)
Description	Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).
Time Frame	3 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	37 11.5%	15 7%

22. Secondary Outcome

Title	Number of Participants With Target Vessel Failure(TVF)
Description	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame	4 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length).There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted, and target lesion characteristics other than lesion lengths. XIENCE PRIME - Long Length (LL): Long Length	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted, and target lesion characteristics other than lesion lengths. XIENCE PRIME - Core Size: Core Size
Measure Participants	323	213
Count of Participants [Participants]	43 13.3%	17 8%

23. Secondary Outcome

Title	Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)
Description	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame	8 months post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	8 2.5%	2 0.9%

24. Secondary Outcome

Title	Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)
Description	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame	1 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths. .	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	17 5.3%	6 2.8%

25. Secondary Outcome

Title	Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)
Description	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame	2 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	21 6.5%	9 4.2%

26. Secondary Outcome

Title	Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)
Description	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame	3 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	26 8%	9 4.2%

27. Secondary Outcome

Title	Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)
Description	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame	4 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	30 9.3%	9 4.2%

28. Secondary Outcome

Title	Number of Participants With Death or Myocardial Infarction (MI)
Description	All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame	8 months post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	5 1.5%	5 2.3%

29. Secondary Outcome

Title	Number of Participants With Death or Myocardial Infarction (MI)
Description	All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame	1 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	7 2.2%	9 4.2%

30. Secondary Outcome

Title	Number of Participants With Death or Myocardial Infarction (MI)
Description	All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame	2 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	16 5%	11 5.2%

31. Secondary Outcome

Title	Number of Participants With Death or Myocardial Infarction (MI)
Description	All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame	3 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	23 7.1%	13 6.1%

32. Secondary Outcome

Title	Number of Participants With Death or Myocardial Infarction (MI)
Description	All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame	4 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	29 9%	15 7%

33. Secondary Outcome

Title	Number of Participants With Cardiac Death or Myocardial Infarction (MI)
Description	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	8 months post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	4 1.2%	1 0.5%

34. Secondary Outcome

Title	Number of Participants With Cardiac Death or Myocardial Infarction (MI)
Description	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	1 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	6 1.9%	3 1.4%

35. Secondary Outcome

Title	Number of Participants With Cardiac Death or Myocardial Infarction (MI)
Description	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	2 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	7 2.2%	3 1.4%

36. Secondary Outcome

Title	Number of Participants With Cardiac Death or Myocardial Infarction (MI)
Description	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	3 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	10 3.1%	3 1.4%

37. Secondary Outcome

Title	Number of Participants With Cardiac Death or Myocardial Infarction (MI)
Description	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	4 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	11 3.4%	3 1.4%

38. Secondary Outcome

Title	Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)
Description	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction.
Time Frame	8 months post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	4 1.2%	1 0.5%

39. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	6 1.9%	1 0.5%

40. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	6 1.9%	1 0.5%

41. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	7 2.2%	1 0.5%

42. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	7 2.2%	1 0.5%

43. Secondary Outcome

Title	Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)
Description	Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma
Time Frame	8 months post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	4 1.2%	5 2.3%

44. Secondary Outcome

Title	Number of of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)
Description	Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma
Time Frame	1 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	5 1.5%	6 2.8%

45. Secondary Outcome

Title	Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)
Description	Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma
Time Frame	2 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	11 3.4%	8 3.8%

46. Secondary Outcome

Title	Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)
Description	Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma
Time Frame	3 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	16 5%	11 5.2%

47. Secondary Outcome

Title	Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)
Description	Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma
Time Frame	4 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	19 5.9%	13 6.1%

48. Secondary Outcome

Title	Number of Participants With Myocardial Infarction (MI)
Description	Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame	8 months post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	1 0.3%	0 0%

49. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	2 0.6%	2 0.9%

50. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	3 0.9%	2 0.9%

51. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	5 1.5%	2 0.9%

52. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	6 1.9%	2 0.9%

53. Secondary Outcome

Title	Number of Participants With Target Lesion Revascularization (TLR)
Description	Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR. Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Time Frame	8 months post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	7 2.2%	1 0.5%

54. Secondary Outcome

Title	Number of Participants With Target Lesion Revascularization (TLR)
Description	Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR. Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Time Frame	1 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	16 5%	5 2.3%

55. Secondary Outcome

Title	Number of Participants With Target Lesion Revascularization (TLR)
Description	Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR. Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Time Frame	2 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	23 7.1%	8 3.8%

56. Secondary Outcome

Title	Number of Participants With Target Lesion Revascularization (TLR)
Description	Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR. Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Time Frame	3 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	26 8%	8 3.8%

57. Secondary Outcome

Title	Number of Participants With Target Lesion Revascularization(TLR)
Description	Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR. Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Time Frame	4 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	29 9%	9 4.2%

58. Secondary Outcome

Title	Number of Participants With Non-Target Lesion Revascularization (Non-TLR)
Description	Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
Time Frame	8 months post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	5 1.5%	4 1.9%

59. Secondary Outcome

Title	Number of Participants With Non-Target Lesion Revascularization (Non-TLR)
Description	Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
Time Frame	1 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	12 3.7%	8 3.8%

60. Secondary Outcome

Title	Number of Participants With Non-Target Lesion Revascularization (Non-TLR)
Description	Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
Time Frame	2 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	16 5%	11 5.2%

61. Secondary Outcome

Title	Number of Participants With Non-Target Lesion Revascularization (Non-TLR)
Description	Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
Time Frame	3 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	17 5.3%	15 7%

62. Secondary Outcome

Title	Number of Participants With Non-Target Lesion Revascularization (Non-TLR)
Description	Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
Time Frame	4 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	20 6.2%	17 8%

63. Secondary Outcome

Title	Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))
Description	Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)
Time Frame	8 months post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	12 3.7%	5 2.3%

64. Secondary Outcome

Title	Number of Participants With Target Vessel Revascularization (TLR or TVR ( Non-TLR))
Description	Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)
Time Frame	1 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	28 8.7%	13 6.1%

65. Secondary Outcome

Title	Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))
Description	Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)
Time Frame	2 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	37 11.5%	19 8.9%

66. Secondary Outcome

Title	Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))
Description	Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)
Time Frame	3 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	41 12.7%	23 10.8%

67. Secondary Outcome

Title	Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))
Description	Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)
Time Frame	4 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	46 14.2%	25 11.7%

68. Secondary Outcome

Title	Number of Participants With Non-Target Vessel Revascularization (Non-TVR)
Description	Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.
Time Frame	8 months post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	18 5.6%	4 1.9%

69. Secondary Outcome

Title	Number of Participants With Non-Target Vessel Revascularization (Non-TVR)
Description	Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.
Time Frame	1 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	34 10.5%	9 4.2%

70. Secondary Outcome

Title	Number of Participants With Non-Target Vessel Revascularization (Non-TVR)
Description	Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.
Time Frame	2 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	43 13.3%	15 7%

71. Secondary Outcome

Title	Number of Participants With Non-Target Vessel Revascularization (Non-TVR)
Description	Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.
Time Frame	3 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	50 15.5%	19 8.9%

72. Secondary Outcome

Title	Number of Participants With Non-Target Vessel Revascularization (Non-TVR)
Description	Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.
Time Frame	4 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	57 17.6%	25 11.7%

73. Secondary Outcome

Title	Number of Participants With All Revascularization
Description	All revascularization includes ischemia driven and non-ischemia driven revascularization.
Time Frame	8 months post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	28 8.7%	9 4.2%

74. Secondary Outcome

Title	Number of Participants With All Revascularization
Description	All revascularization includes ischemia driven and non-ischemia driven revascularization.
Time Frame	1 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	57 17.6%	22 10.3%

75. Secondary Outcome

Title	Number of Participants With All Revascularization
Description	All revascularization includes ischemia driven and non-ischemia driven revascularization.
Time Frame	2 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	72 22.3%	33 15.5%

76. Secondary Outcome

Title	Number of Participants With All Revascularization
Description	All revascularization includes ischemia driven and non-ischemia driven revascularization.
Time Frame	3 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	77 23.8%	37 17.4%

77. Secondary Outcome

Title	Number of Participants With All Revascularization
Description	All revascularization includes ischemia driven and non-ischemia driven revascularization.
Time Frame	4 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	87 26.9%	45 21.1%

78. Secondary Outcome

Title	Number of Participants Experienced Bleeding
Description	Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding
Time Frame	8 months post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	0 0%	1 0.5%

79. Secondary Outcome

Title	Number of Participants Experienced Bleeding
Description	Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding
Time Frame	1 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	0 0%	2 0.9%

80. Secondary Outcome

Title	Number of Participants Experienced Bleeding
Description	Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding
Time Frame	2 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	0 0%	4 1.9%

81. Secondary Outcome

Title	Number of Participants Experienced Bleeding
Description	Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding
Time Frame	3 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	1 0.3%	4 1.9%

82. Secondary Outcome

Title	Number of Participants Experienced Bleeding
Description	Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events. Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding
Time Frame	4 year post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed excludes subjects who were lost-to-follow-up.

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Count of Participants [Participants]	1 0.3%	4 1.9%

83. Secondary Outcome

Title	Percent Diameter Stenosis (%DS)
Description	The value calculated as 100 * (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Measure Number of lesion analyzed	377	245
Mean (Standard Deviation) [percentage of DS]	73.96 (17.73)	70.27 (15.13)

84. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Measure Number of lesion analyzed	375	245
Mean (Standard Deviation) [percentage of DS]	25.94 (11.76)	23.58 (10.79)

85. Secondary Outcome

Title	Percent Diameter Stenosis (%DS)
Description	The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Time Frame	8 months post index procedure

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	237	154
Measure Number of lesion analyzed	275	175
Mean (Standard Deviation) [percentage of DS]	29.17 (15.50)	25.12 (12.88)

86. Secondary Outcome

Title	Acute Gain: In-stent, In-segment
Description	The difference between post- and pre-procedural MLD.
Time Frame	8 months post index procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Measure Lesions	375	244
Stent	1.81 (0.56)	1.81 (0.53)
Segment	1.42 (0.62)	1.40 (0.61)

87. Secondary Outcome

Title	Net Gain: In-stent, In-segment
Description	Late procedural outcome is influenced by both the acute gain provided by the intervention (pre to post) and the subsequent late loss that occurs after the intervention (post to follow-up).The net gain is thus the sum of the offsetting effects of acute gain and late loss (net gain = acute gain - late loss).
Time Frame	8 months post index procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Measure Lesions	273	174
Stent	1.53 (0.66)	1.68 (0.58)
Segment	1.31 (0.67)	1.34 (0.64)

88. Secondary Outcome

Title	Late Loss(LL): In-stent, In-segment, Proximal, and Distal
Description	Late loss is calculated as MLD post procedure - MLD at follow-up.
Time Frame	8 months post index procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XIENCE PRIME - Long Length (LL)	XIENCE PRIME - Core Size
Arm/Group Description	Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.	Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
Measure Participants	323	213
Measure Lesions	273	175
Stent	0.27 (0.41)	0.15 (0.29)
Proximal	0.13 (0.44)	0.08 (0.40)
Distal	-0.04 (0.36)	0.03 (0.35)
Segment	0.12 (0.50)	0.06 (0.45)

Adverse Events

Time Frame	4 years
Adverse Event Reporting Description	This Surveillance is conducted per the Ministerial Ordinance on Good PMS Practice for Medical Devices to measure the frequency&status of adverse device effects&AEs in order to assure the safety of the new medical device to be evaluated for repeat review by PMDA. PMDA has requested for a combined AE for follow up period, as the difference between both the groups are just based on length of the device,which does not signify a change in the technology but the same technology applies.
Arm/Group Title	XIENCE PRIME - Long Length (LL) and Core Size (CS)
Arm/Group Description	The study has 2 arms depending upon the size of stent used for the treatment: Long Lesion Arm patients (n=323) are treated by at least one Long Size stent (28, 33 and 38 mm length), whereas Core Size Arm patients (n=213) are treated with small size stent (8, 12, 15, 18 and 23 mm length). There are no significant difference between both the groups with respect to patient background, ischemic status, risk factors and medical history, numbers of target lesions and the lesion types, target lesion treatment, number of stents implanted and target lesion characteristics other than lesion lengths.
All Cause Mortality
	XIENCE PRIME - Long Length (LL) and Core Size (CS)
	Affected / at Risk (%)	# Events
Total	47/536 (8.8%)
Serious Adverse Events
	XIENCE PRIME - Long Length (LL) and Core Size (CS)
	Affected / at Risk (%)	# Events
Total	221/536 (41.2%)
Blood and lymphatic system disorders
Anemia	3/536 (0.6%)
Cardiac disorders
Acute heart failure	1/536 (0.2%)
Acute myocardial infarction	5/536 (0.9%)
Angina pectoris	48/536 (9%)
Angina unstable	10/536 (1.9%)
Angiopathy	12/536 (2.2%)
Aortic aneurysm	2/536 (0.4%)
Aortic dissection	1/536 (0.2%)
Aortic valve stenosis	2/536 (0.4%)
Atrial fibrillation	1/536 (0.2%)
Atrial tachycardia	1/536 (0.2%)
Cardio respiration	1/536 (0.2%)
Cardiogenic shock	1/536 (0.2%)
Chronic heart failure	7/536 (1.3%)
Complete atrioventricular block	1/536 (0.2%)
Congestive heart failure	3/536 (0.6%)
Contractile pericarditis	1/536 (0.2%)
Coronary artery disease	1/536 (0.2%)
Coronary artery stenosis	47/536 (8.8%)
Heart failure	23/536 (4.3%)
Intermittent claudication	1/536 (0.2%)
Myocardial infarction	1/536 (0.2%)
Myocardial ischemia	6/536 (1.1%)
Peripheral arterial obstructive disease	11/536 (2.1%)
Peripheral ischemia	1/536 (0.2%)
Prinzmetal angina	1/536 (0.2%)
Second degree atrioventricular block	1/536 (0.2%)
Sick sinus syndrome	2/536 (0.4%)
Supraventricular arrhythmia	5/536 (0.9%)
Ventricular arrhythmia	1/536 (0.2%)
Ventricular extrasystole	1/536 (0.2%)
Ventricular fibrillation	1/536 (0.2%)
Ventricular tachycardia	1/536 (0.2%)
Ear and labyrinth disorders
Dizziness, vertigo	1/536 (0.2%)
Eye disorders
Diabetic retinopathy	2/536 (0.4%)
Macular hole	1/536 (0.2%)
Gastrointestinal disorders
Ascites	1/536 (0.2%)
Atrophic gastritis	1/536 (0.2%)
Colon Bleeding	1/536 (0.2%)
Colonic polyp	5/536 (0.9%)
Colorectal polyp	1/536 (0.2%)
Gastrointestinal Bleeding	1/536 (0.2%)
Ileus	1/536 (0.2%)
Intestinal polyp	1/536 (0.2%)
Ischemic colitis	1/536 (0.2%)
General disorders
Asthenia	1/536 (0.2%)
Death	47/536 (8.8%)
Thrombosis in device	3/536 (0.6%)
Hepatobiliary disorders
Acute cholangitis	1/536 (0.2%)
Acute cholecystitis	3/536 (0.6%)
Bile duct stones	1/536 (0.2%)
Cholangitis	2/536 (0.4%)
Liver cirrhosis	1/536 (0.2%)
Infections and infestations
Abdominal wall abscess	1/536 (0.2%)
Acute pyelonephritis	1/536 (0.2%)
Appendicitis	1/536 (0.2%)
Cellulitis	1/536 (0.2%)
Diabetic gangrene	1/536 (0.2%)
Discitis	2/536 (0.4%)
Diverticulitis	1/536 (0.2%)
Herpes zoster	1/536 (0.2%)
Infection	2/536 (0.4%)
Influenza	1/536 (0.2%)
Liver abscess	1/536 (0.2%)
Lymph node tuberculosis	1/536 (0.2%)
Lymphangitis	1/536 (0.2%)
Muscle abscess	1/536 (0.2%)
Pneumonia	9/536 (1.7%)
Pyelonephritis	4/536 (0.7%)
Pyoderma	2/536 (0.4%)
Sepsis	3/536 (0.6%)
Sepsis shock	1/536 (0.2%)
Urinary tract Infection	1/536 (0.2%)
Injury, poisoning and procedural complications
Cerebral contusion	1/536 (0.2%)
Cervical vertebral fracture	1/536 (0.2%)
Compression fracture	1/536 (0.2%)
Coronary artery restenosis	31/536 (5.8%)
Femoral fracture	1/536 (0.2%)
Graft vascular occlusion	1/536 (0.2%)
Ligament injury	2/536 (0.4%)
Ligament tear	1/536 (0.2%)
Shunt obstruction	1/536 (0.2%)
Subdural hematoma	1/536 (0.2%)
Vascular pseudoaneurysm	1/536 (0.2%)
Investigations
Exercise test abnormal	1/536 (0.2%)
Motor test abnormality	2/536 (0.4%)
Metabolism and nutrition disorders
Dehydration	2/536 (0.4%)
Hyperkalemia	2/536 (0.4%)
Hypoglycaemia	2/536 (0.4%)
Malnutrition	1/536 (0.2%)
Marasmus	1/536 (0.2%)
Musculoskeletal and connective tissue disorders
Crystalline joint disorder	1/536 (0.2%)
Intervertebral stenosis	1/536 (0.2%)
Intramuscular Bleeding	1/536 (0.2%)
Lumbar spinal stenosis	1/536 (0.2%)
Rhabdomyolysis	1/536 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer	2/536 (0.4%)
Breast cancer	1/536 (0.2%)
Colon cancer	2/536 (0.4%)
Esophageal cancer	1/536 (0.2%)
Lung cancer metastatic	2/536 (0.4%)
Lymphoma	1/536 (0.2%)
Malignant neoplasm of renal pelvis	1/536 (0.2%)
Malignant neoplasm of the liver	1/536 (0.2%)
Malignant neoplasm of the tongue, stage unknown	1/536 (0.2%)
Metastatic pancreatic cancer	2/536 (0.4%)
Prostate cancer	1/536 (0.2%)
Rectal cancer	1/536 (0.2%)
Rectal sigmoid carcinoma	2/536 (0.4%)
Recurrent liver malignant neoplasm	1/536 (0.2%)
Stomach cancer	7/536 (1.3%)
Nervous system disorders
Altered state of consciousness	1/536 (0.2%)
Amyotrophic lateral sclerosis	1/536 (0.2%)
Carotid artery stenosis	2/536 (0.4%)
Cerebellar infarction	1/536 (0.2%)
Cerebral infarction	5/536 (0.9%)
Dementia with Lewy bodies	1/536 (0.2%)
Diabetic neuropathy	1/536 (0.2%)
Embolic stroke	2/536 (0.4%)
Floating dizziness	2/536 (0.4%)
Hepatic encephalopathy	1/536 (0.2%)
Hypoglycaemic coma	1/536 (0.2%)
Lacunar infarct	1/536 (0.2%)
Subarachnoid hemorrhage	1/536 (0.2%)
Transient ischemic attack	1/536 (0.2%)
Renal and urinary disorders
Acute renal failure	1/536 (0.2%)
Chronic renal failure	1/536 (0.2%)
Kidney failure	2/536 (0.4%)
Renal dysfunction	4/536 (0.7%)
Reproductive system and breast disorders
Prostatitis	1/536 (0.2%)
Respiratory, thoracic and mediastinal disorders
Aspiration Pneumonia	3/536 (0.6%)
Asthma	3/536 (0.6%)
Pleural effusion	3/536 (0.6%)
Pneumothorax	1/536 (0.2%)
Sleep apnea syndrome	1/536 (0.2%)
Surgical and medical procedures
Medical device related thrombosis	3/536 (0.6%)
Medical equipment blockage	1/536 (0.2%)
Vascular disorders
Aortic aneurysm	2/536 (0.4%)
Peripheral arterial occlusive disease	4/536 (0.7%)
Peripheral ischemia	1/536 (0.2%)
Other (Not Including Serious) Adverse Events
	XIENCE PRIME - Long Length (LL) and Core Size (CS)
	Affected / at Risk (%)	# Events
Total	254/536 (47.4%)
Blood and lymphatic system disorders
Anemia	3/536 (0.6%)
Cardiac disorders
Angina pectoris	58/536 (10.8%)
Coronary artery stenosis	54/536 (10.1%)
Acute myocardial infarction	5/536 (0.9%)
Unstable angina	13/536 (2.4%)
Aortic valve stenosis	2/536 (0.4%)
Supra ventricular arrhythmia	7/536 (1.3%)
Atrial fibrillation	1/536 (0.2%)
Atrial tachycardia	1/536 (0.2%)
Complete atrioventricular block	1/536 (0.2%)
Second degree atrioventricular block	1/536 (0.2%)
Heart failure	23/536 (4.3%)
Cardio respiration	1/536 (0.2%)
Cardiogenic shock	1/536 (0.2%)
Coronary artery disease	1/536 (0.2%)
Coronary embolism	2/536 (0.4%)
Myocardial infarction	1/536 (0.2%)
Myocardial ischemia	10/536 (1.9%)
Contractile pericarditis	1/536 (0.2%)
Prinzmetal angina	1/536 (0.2%)
Sick sinus syndrome	2/536 (0.4%)
Ventricular arrhythmia	1/536 (0.2%)
Ventricular extrasystole	1/536 (0.2%)
Ventricular fibrillation	1/536 (0.2%)
Ventricular tachycardia	1/536 (0.2%)
Coronary dissection	4/536 (0.7%)
Cardiac puncture	2/536 (0.4%)
Coronary artery no re flow phenomenon	1/536 (0.2%)
Angiopathy	17/536 (3.2%)
Aortic aneurysm	2/536 (0.4%)
Aortic dissection	1/536 (0.2%)
Intermittent claudication	1/536 (0.2%)
Peripheral ischemia	1/536 (0.2%)
Peripheral arterial obstructive disease	11/536 (2.1%)
Reperfusion injury	5/536 (0.9%)
Acute heart failure	1/536 (0.2%)
Chronic heart failure	7/536 (1.3%)
Congestive heart failure	3/536 (0.6%)
Ear and labyrinth disorders
Dizziness, vertigo	1/536 (0.2%)
Eye disorders
Diabetic retinopathy	2/536 (0.4%)
Macular hole	1/536 (0.2%)
Gastrointestinal disorders
Ascites	1/536 (0.2%)
Ischemic colitis	1/536 (0.2%)
Colonic polyp	5/536 (0.9%)
Atrophic gastritis	1/536 (0.2%)
Gastrointestinal bleeding	2/536 (0.4%)
Ileus	1/536 (0.2%)
Intestinal polyp	1/536 (0.2%)
Colorectal polyp	1/536 (0.2%)
Colon bleeding	1/536 (0.2%)
General disorders
Asthenia	1/536 (0.2%)
Can not pass target lesion	2/536 (0.4%)
Hepatobiliary disorders
Bile duct stone	1/536 (0.2%)
Cholangitis	2/536 (0.4%)
Acute cholecystitis	3/536 (0.6%)
Liver cirrhosis	1/536 (0.2%)
Acute cholangitis	1/536 (0.2%)
Immune system disorders
Drug hypersensitivity	1/536 (0.2%)
Infections and infestations
Appendicitis	1/536 (0.2%)
Cellulitis	1/536 (0.2%)
Diabetic gangrene	1/536 (0.2%)
Diverticulitis	1/536 (0.2%)
Herpes zoster	1/536 (0.2%)
Infection	2/536 (0.4%)
Influenza	1/536 (0.2%)
Liver abscess	1/536 (0.2%)
Lymph node tuberculosis	1/536 (0.2%)
Lymphangitis	1/536 (0.2%)
Pneumonia	9/536 (1.7%)
Pyelonephritis	4/536 (0.7%)
Pyoderma	2/536 (0.4%)
Sepsis	3/536 (0.6%)
Septic shock	1/536 (0.2%)
Urinary tract infection	1/536 (0.2%)
Muscle abscess	1/536 (0.2%)
Abdominal segment abscess	1/536 (0.2%)
Disc flame	2/536 (0.4%)
Acute pyelonephritis	1/536 (0.2%)
Injury, poisoning and procedural complications
Compression fracture	1/536 (0.2%)
Femoral fracture	1/536 (0.2%)
Shunt obstruction	1/536 (0.2%)
Subdural hematoma	1/536 (0.2%)
Vascular pseudoaneurysm	1/536 (0.2%)
Graft vascular occlusion	1/536 (0.2%)
Cervical vertebral fracture	1/536 (0.2%)
Contusion	1/536 (0.2%)
Cerebral contusion	1/536 (0.2%)
Coronary restenosis	38/536 (7.1%)
Ligament injury	2/536 (0.4%)
Ligament tear	1/536 (0.2%)
Balloon rupture	1/536 (0.2%)
Investigations
Increased myocardial enzyme	1/536 (0.2%)
Motor test abnormality	2/536 (0.4%)
Metabolism and nutrition disorders
Dehydration	2/536 (0.4%)
Hyperkalemia	2/536 (0.4%)
Hypoglycemia	2/536 (0.4%)
Marasmus	1/536 (0.2%)
Malnutrition	1/536 (0.2%)
Hypoglycemia coma	1/536 (0.2%)
Musculoskeletal and connective tissue disorders
Lumbar spinal canal stenosis	1/536 (0.2%)
Intramuscular hemorrhage	1/536 (0.2%)
Rhabdomyolysis	1/536 (0.2%)
Crystalline joint disorder	1/536 (0.2%)
Intervertebral stenosis	1/536 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer	2/536 (0.4%)
Breast cancer	1/536 (0.2%)
Colon cancer	2/536 (0.4%)
Stomach cancer	7/536 (1.3%)
Liver malignant neoplasm	2/536 (0.4%)
Lymphoma	1/536 (0.2%)
Malignant neoplasm of renal pelvis	1/536 (0.2%)
Esophageal cancer	1/536 (0.2%)
Metastatic pancreatic cancer	2/536 (0.4%)
Rectal cancer	1/536 (0.2%)
Malignant neoplasm of the tongue, stage unknown	1/536 (0.2%)
Metastatic lung cancer	2/536 (0.4%)
Prostate cancer	1/536 (0.2%)
Rectal sigmoid carcinoma	2/536 (0.4%)
Nervous system disorders
State of consciousness transformation	1/536 (0.2%)
Amyotrophic lateral sclerosis	1/536 (0.2%)
Carotid stenosis	2/536 (0.4%)
Cerebellar infarction	1/536 (0.2%)
Cerebral infarction	5/536 (0.9%)
Diabetic neuropathy	1/536 (0.2%)
Floating dizziness	2/536 (0.4%)
Hepatic encephalopathy	1/536 (0.2%)
Subarachnoid hemorrhage	1/536 (0.2%)
Transient ischemic attack	1/536 (0.2%)
Lacunar infarct	1/536 (0.2%)
Embolic stroke	2/536 (0.4%)
Lewy body dementia	1/536 (0.2%)
Product Issues
Tearing	1/536 (0.2%)
Stent damaged / deformed after indwelling-others	1/536 (0.2%)
Renal and urinary disorders
Hematuria	1/536 (0.2%)
Acute renal failure	1/536 (0.2%)
Renal dysfunction	4/536 (0.7%)
Chronic renal failure	1/536 (0.2%)
Kidney failure	2/536 (0.4%)
Reproductive system and breast disorders
Prostatitis	1/536 (0.2%)
Respiratory, thoracic and mediastinal disorders
Asthma	3/536 (0.6%)
Nose bleeding	2/536 (0.4%)
Pleural effusion	3/536 (0.6%)
Aspiration pneumonia	3/536 (0.6%)
Pneumothorax	1/536 (0.2%)
Sleep apnea syndrome	1/536 (0.2%)
Skin and subcutaneous tissue disorders
Drug eruption	1/536 (0.2%)
Surgical and medical procedures
Medical device related thrombosis	3/536 (0.6%)
Medical device obstruction	1/536 (0.2%)

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.