XIENCE PRIME SV Everolimus Eluting Coronary Stent Japan Post Marketing Surveillance (XIENCE PRIME SV Japan PMS)

Browse trials for

• Coronary Artery Disease 5,598
• Myocardial Ischemia 3,233
• Heart Diseases 3,639
• Angina Pectoris 519
• Coronary Occlusion 81

Keywords

• drug eluting stent
• stent
• real world

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's enrollment of 312 is close to the median of 336 across 1,946 observational studies indexed under Coronary Artery Disease.

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Study population

Eligibility criteria

Groups and cohorts

• XIENCE PRIME SV Everolimus Eluting Coronary Stent

  Patients receiving XIENCE PRIME SV Everolimus Eluting Coronary Stent

  Device: XIENCE PRIME SV Everolimus Eluting Coronary Stent

Interventions

• DeviceXIENCE PRIME SV Everolimus Eluting Coronary Stent

  Patients receiving XIENCE PRIME SV Everolimus Eluting Stent

Primary outcomes

1. Number of Participants With Stent Thrombosis: Acute

   Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timing: Acute stent thrombosis: 0 to 24 hours after stent implantation

   Time frame: 0-24 hours post stent implantation

2. Number of Participants With Stent Thrombosis: Subacute

   Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Subacute stent thrombosis : \>24 hours to 30 days after stent implantation

   Time frame: >24 hours to 30 days post stent implantation

3. Number of Participants With Stent Thrombosis: Late

   Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Late stent thrombosis : \>30 days to 1 year after stent implantation

   Time frame: 30 days to 1 year post stent implantation

Secondary outcomes

1. Number of Participants With Stent Thrombosis: Very Late

   Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Very late stent thrombosis : \>1 year after stent implantation.

   Time frame: >1 year post stent implantation

2. Percent Diameter Stenosis (%DS)

   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: Pre-procedure

3. Percent Diameter Stenosis (%DS)

   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: post procedure (on day 0)

4. Percent Diameter Stenosis (%DS)

   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: 8 months

5. Success Rate: Percentage of Devices With Implant Success

   The stent lengths used were 8 mm, 12 mm, and 15 mm,18 mm, 23 mm, and 28 mm and the stent diameter was 2.25mm. 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: < or = 1 day

6. Success Rate: Percentage of Lesions With Procedural Success

   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: < or = 1 day

7. Success Rate: XIENCE PRIME Implant Success by Patient

   The stent lengths used were 8 mm, 12 mm, and 15 mm,18 mm, 23 mm, and 28 mm and the stent diameter was 2.25 mm. Implant success is assessed as per physicians decision, but means that the stent could be implanted at the intended location.

   Time frame: < or = 1 day

8. Number of Death

   Death includes cardiac death, non-cardiac death and non-coronary death.

   Time frame: 0 to 8 months

9. Number of Death

   All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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: 0 to 1 year

10. Number of Death

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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: 0 to 2 years

11. Number of Death

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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: 0-3 years

12. Number of Death

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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: 0-4 years

13. Number of Death

    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • 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: 0-５ years

14. Number of Participants With Myocardial Infarction

    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: 0 to 8 months

15. Number of Participants With Myocardial Infarction

    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: 0 to 1 year

16. Number of Participants With Myocardial Infarction

    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: 0 to 2 years

17. Number of Participants With Myocardial Infarction

    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: 0-3 years

18. Number of Participants With Myocardial Infarction

    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: 0-4 years

19. Number of Participants With Myocardial Infarction

    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: 0-5 years

20. Number of Participants With Target Lesion Revascularization

    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. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR

    Time frame: 0 to 8 months

21. Number of Participants With Target Lesion Revascularization

    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. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR

    Time frame: 0 to 1 year

22. Number of Participants With Target Lesion Revascularization

    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. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR

    Time frame: 0 to 2 years

23. Number of Participants With Target Lesion Revascularization

    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. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR

    Time frame: 0-3 years

24. Number of Participants With Target Lesion Revascularization

    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. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR

    Time frame: 0-4 years

25. Number of Participants With Target Lesion Revascularization

    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. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR

    Time frame: 0-5 years

26. Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)

    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: 0 to 8 months

27. Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)

    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: 0 to 1 year

28. Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)

    The number of patient with Ischemia-driven Target vessel revascularization (TLR or TVR, non-TLR)

    Time frame: 0 to 2 years

29. Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)

    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: 0-3 years

30. Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)

    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: 0-4 years

31. Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)

    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: 0-5 years

32. Number of Participants With Non-target Vessel Revascularization (Non-TVR)

    Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.

    Time frame: 0 to 8 months

33. Number of Participants With Non-target Vessel Revascularization (Non-TVR)

    Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.

    Time frame: 0 to 1 year

34. Number of Participants With Non-target Vessel Revascularization (Non-TVR)

    Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.

    Time frame: 0 to 2 years

35. Number of Participants With Non-target Vessel Revascularization (Non-TVR)

    Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.

    Time frame: 0 to 3 years

36. Number of Participants With Non-target Vessel Revascularization (Non-TVR)

    Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.

    Time frame: 0 to 4 years

37. Number of Participants With Non-target Vessel Revascularization (Non-TVR)

    Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.

    Time frame: 0 to 5 years

38. Number of Participants With All Revascularization

    Revascularization: * Target Lesion Revascularization (TLR) 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. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. * Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. * Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. * Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

    Time frame: 0 to 8 months

39. Number of Participants With All Revascularization

    Revascularization: * Target Lesion Revascularization (TLR) 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. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. * Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. * Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. * Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

    Time frame: 0 to 1 year

40. Number of Participants With All Revascularization

    Revascularization: * Target Lesion Revascularization (TLR) 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. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. * Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. * Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. * Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

    Time frame: 0 to 2 years

41. Number of Participants With All Revascularization

    Revascularization: * Target Lesion Revascularization (TLR) 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. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. * Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. * Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. * Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

    Time frame: 0 to 3 years

42. Number of Participants With All Revascularization

    Revascularization: * Target Lesion Revascularization (TLR) 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. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. * Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. * Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. * Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

    Time frame: 0 to 4 years

43. Number of Participants With All Revascularization

    Revascularization: * Target Lesion Revascularization (TLR) 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. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. * Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. * Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. * Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

    Time frame: 0 to 5 years

44. Number of Participants With Hemorrhage

    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: 0 to 8 months

45. Number of Participants With Hemorrhage

    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: 0 to 1 year

46. Number of Participants With Hemorrhage

    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: 0 to 2 years

47. Number of Participants With Hemorrhage

    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: 0 to 3 years

48. Number of Participants With Hemorrhage

    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: 0 to 4 years

49. Number of Participants With Hemorrhage

    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: 0 to 5 years

50. Number of Participants With Target Lesion Failure

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Time frame: 0 to 8 months

51. Number of Participants With Target Lesion Failure

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Time frame: 0 to 1 year

52. Number of Participants With Target Lesion Failure

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Time frame: 0 to 2 years

53. Number of Participants With Target Lesion Failure

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Time frame: 0 to 3 years

54. Number of Participants With Target Lesion Failure

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Time frame: 0 to 4 years

55. Number of Participants With Target Lesion Failure

    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

    Time frame: 0 to 5 years

56. Number of Participants With All Death/All MI/All Revascularization

    Time frame: 0 to 8 months

57. Number of Participants With All Death/All MI/All Revascularization

    Time frame: 0 to 1 year

58. Number of Participants With All Death/All MI/All Revascularization

    Time frame: 0 to 2 years

59. Number of Participants With All Death/All MI/All Revascularization

    Time frame: 0 to 3 years

60. Number of Participants With All Death/All MI/All Revascularization

    Time frame: 0 to 4 years

61. Number of Participants With All Death/All MI/All Revascularization

    Time frame: 0 to 5 years

62. Number of Participants With Target Vessel Failure

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

    Time frame: 0 to 8 months

63. Number of Participants With Target Vessel Failure

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

    Time frame: 0 to 1 year

64. Number of Participants With Target Vessel Failure

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

    Time frame: 0 to 2 years

65. Number of Participants With Target Vessel Failure

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

    Time frame: 0 to 3 years

66. Number of Participants With Target Vessel Failure

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

    Time frame: 0 to 4 years

67. Number of Participants With Target Vessel Failure

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

    Time frame: 0 to 5 years

68. Number of Participants With Major Adverse Cardiac Events (MACE)

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

    Time frame: 0 to 8 months

69. Number of Participants With Major Adverse Cardiac Events (MACE)

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

    Time frame: 0 to 1 year

70. Number of Participants With Major Adverse Cardiac Events (MACE)

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

    Time frame: 0 to 2 years

71. Number of Participants With Major Adverse Cardiac Events (MACE)

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

    Time frame: 0 to 3 years

72. Number of Participants With Major Adverse Cardiac Events (MACE)

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

    Time frame: 0 to 4 years

73. Number of Participants With Major Adverse Cardiac Events (MACE)

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

    Time frame: 0 to 5 years

74. Number of Participants With Death or MI

    All deaths includes * 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 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: 0 to 8 months

75. Number of Participants With Death or MI

    All deaths includes * 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 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: 0 to 1 year

76. Number of Participants With Death or MI

    All deaths includes 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 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: 0 to 2 years

77. Number of Participants With Death or MI

    All deaths includes 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 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: 0 to 3 years

78. Number of Participants With Death or MI

    All deaths includes 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 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: 0 to 4 years

79. Number of Participants With Death or MI

    All deaths includes 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 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: 0 to 5 years

80. Number of Participants With Cardiac Death or MI

    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: 0 to 8 months

81. Number of Participants With Cardiac Death or MI

    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: 0 to 1 year

82. Number of Participants With Cardiac Death or MI

    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: 0 to 2 years

83. Number of Participants With Cardiac Death or MI

    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: 0 to 3 years

84. Number of Participants With Cardiac Death or MI

    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: 0 to 4 years

85. Number of Participants With Cardiac Death or MI

    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: 0 to 5 years

86. Number of Participants With Cardiac Death or Target-Vessel MI

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

    Time frame: 0 to 8 months

87. Number of Participants With Cardiac Death or Target Vessel-MI

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

    Time frame: 0 to 1 year

88. Number of Participants With Cardiac Death or Target Vessel MI

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

    Time frame: 0 to 2 years

89. Number of Participants With Cardiac Death or Target Vessel MI

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

    Time frame: 0 to 3 years

90. Number of Participants With Cardiac Death or Target Vessel MI

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

    Time frame: 0 to 4 years

91. Number of Participants With Cardiac Death or Target Vessel MI

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

    Time frame: 0 to 5 years

92. Acute Gain: In-stent,In-segment

    The acute gain was defined as the difference between post- and preprocedural minimal lumen diameter (MLD).

    Time frame: Pre procedure to post procedure (on day 0)

93. Late Loss(LL): In-stent,In-segment,Proximal, and Distal

    Proximal and distal late loss was calculated by \[post-procedure minimum lumen diameter (MLD)\] - \[MLD at 8 months\].

    Time frame: 8 months

94. Net Gain: In-stent, In-segment

    Difference between acute gain and late loss.

    Time frame: Post-Procedure (on day 0)

Baseline characteristics

Study documents

• Study protocol · Mar 15, 2013
• Statistical analysis plan · Jan 7, 2020

Documents are hosted by the registry — open the source record to download them.