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OpenTrials
Completed

NCT Number: NCT02513732

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

The objective of the study is to evaluate the safety and efficacy of XIENCE Xpedition Everolimus-Eluting 2.25mm Stent in real world practice in Japanese hospitals.

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Key information

Conditions

Ischemic Heart Disease Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hyogo Prefectural Amagasaki Hospital, Hyōgo, Japan

Loading trial locations.

About this study

Based on Good Post-marketing Study Practice (GPSP) regulation, general patient population with ischemic heart disease who are eligible for treatment with XIENCE Xpedition Everolimus-Eluting 2.25mm Stent will be registered, with no particular inclusion/exclusion criteria, and may be eligible for angiographic follow-up at eight months and clinical follow-up at one year.

The XIENCE Xpedition 2.25 mm stent is composed of the stent identical to the stent of the XIENCE PRIME SV Stent.Therefore, the data collected from the PMS will be pooled with data collected from the ongoing XIENCE PRIME SV PMS for analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion criteria
  • Patient informed consent is required for registration of this PMS. In cases where patient informed consent (or providing some type of information) is required for PMS per the participating site policy, the Sponsor will cooperate as needed.
  • Patients who are treated by XIENCE Xpedition 2.25mm stent will be registered.
  • The observations will be compiled on a per-patient basis even if multiple XIENCE Xpedition 2.25mm stents are implanted during the index procedure.
  • A patient whose side-branch is treated by XIENCE Xpedition 2.25mm stent can be registered. In such a case, main vessel should be treated by XIENCE Xpedition.
  • The observations will not be compiled on a per-patient basis if a patient is treated by XIENCE Xpedition 2.25mm stent overlapped with other stents for bail-out purpose.
  • Additional revascularization procedures as a part of adverse event treatment and planned staged procedures will not be considered as another registration, or adverse events.
  • A patient who is treated, but failed to be implanted by XIENCE Xpedition 2.25mm stent and finally treated by other devices only (No XIENCE Xpedition 2.25mm stent are implanted) must also be registered. In such a case, only the stent information, device deficiency information and reportable adverse events related to the Xpedition stent, if any, are required to be captured. Follow-up of the patient who does not receive any XIENCE Xpedition 2.25mm stent is not required.
  • 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.
  • Patients who are attending or will attend other PMS with invasive medical procedure will not be registered.
  • A patient may have another lesion(s) that may be treated by larger diameter (≥ 2.5mm) stent(s). In such a case, treatment by XIENCE Xpedition is preferable. Lesion(s) treated by other than XIENCE Xpedition 2.25mm stent is not considered as the target lesion.

Treatment and study plan

XIENCE Xpedition 2.25 mm stent

Device

Patients receiving XIENCE Xpedition 2.25 mm stent

Primary outcomes

  1. Number of Participants With Stent Thrombosis: Late

    Time frame: 30 days to 1 year post stent implantation-Day 212

    Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate 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:

    Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation

Secondary outcomes

  1. Percent Diameter Stenosis (%DS)

    Time frame: Pre-procedure

    In-segment, In-stent, Proximal and Distal. 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).

  2. Percent Diameter Stenosis (%DS)

    Time frame: Immediately after the procedure

    In-segment, In-stent, Proximal and Distal. The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

  3. Percent Diameter Stenosis (%DS)

    Time frame: During follow-up, at 8 months post procedure

    In-segment, In-stent, Proximal and Distal. The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

  4. Number of Participants Using Antiplatelet Therapy

    Time frame: At baseline before procedure

    Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.

  5. Number of Participants Using Antiplatelet Therapy

    Time frame: Date of discharge from procedure day

    Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.

  6. Number of Participants Using Antiplatelet Therapy

    Time frame: 8 months observation day from the procedure day

    Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.

  7. Number of Participants Using Antiplatelet Therapy

    Time frame: 1 year observation day from the procedure day

    Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.

  8. Number of Participants Using Antiplatelet Therapy

    Time frame: 2 years observation day from the procedure day

    Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.

  9. Number of Participants Using Antiplatelet Therapy

    Time frame: 3 years observation day from the procedure day

    Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.

  10. Number of Participants Using Antiplatelet Therapy

    Time frame: 4 years observation day from the procedure day

    Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.

  11. Number of Participants Using Antiplatelet Therapy

    Time frame: 5 years observation day from the procedure day

    Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.

  12. Number of Participants With Death

    Time frame: During hospitalization

    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.

  13. Number of Participants With Death

    Time frame: 0 to 8 months

    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.

  14. Number of Participants With Death

    Time frame: 0 to 1 year

    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.

  15. Number of Participants With Death

    Time frame: 0 to 2 years

    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.

  16. Number of Participants With Death

    Time frame: 0 to 3 years

    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.

  17. Number of Participants With Death

    Time frame: 0 to 4 years

    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.

  18. Number of Participants With Death

    Time frame: 0 to 5 years

    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.

  19. Number of Participants With Target Lesion Revascularization Based on Ischemia Findings

    Time frame: During hospitalization

    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.

  20. Number of Participants With Target Lesion Revascularization Based on Ischemia Findings

    Time frame: 0 to 8 months

    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.

  21. Number of Participants With Target Lesion Revascularization Based on Ischemia Findings

    Time frame: 0 to 1 year

    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.

  22. Number of Participants With Target Lesion Revascularization Based on Ischemia Findings

    Time frame: 0 to 2 years

    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.

  23. Number of Participants With Target Lesion Revascularization Based on Ischemia Findings

    Time frame: 0 to 3 years

    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.

  24. Number of Participants With Target Lesion Revascularization Based on Ischemia Findings

    Time frame: 0 to 4 years

    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.

  25. Number of Participants With Target Lesion Revascularization Based on Ischemia Findings

    Time frame: 0 to 5 years

    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.

  26. Number of Participants With Myocardial Infarction

    Time frame: During hospitalization

    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.

  27. Number of Participants With Myocardial Infarction

    Time frame: 0 to 8 months

    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

  28. Number of Participants With Myocardial Infarction

    Time frame: 0 to 1 year

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

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

  29. Number of Participants With Myocardial Infarction

    Time frame: 0 to 2 years

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

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

  30. Number of Participants With Myocardial Infarction

    Time frame: 0 to 3 years

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

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

  31. Number of Participants With Myocardial Infarction

    Time frame: 0 to 4 years

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

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

  32. Number of Participants With Myocardial Infarction

    Time frame: 0 to 5 years

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

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

  33. Number of Participants With Cardiac Death

    Time frame: During hospitalization

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

  34. Number of Participants With Cardiac Death

    Time frame: 0 to 8 months

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

  35. Number of Participants With Cardiac Death

    Time frame: 0 to 1 year

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

  36. Number of Participants With Cardiac Death

    Time frame: 0 to 2 years

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

  37. Number of Participants With Cardiac Death

    Time frame: 0 to 3 Years

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

  38. Number of Participants With Cardiac Death

    Time frame: 0 to 4 years

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

  39. Number of Participants With Cardiac Death

    Time frame: 0 to 5 years

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

  40. Number of Participants With MI Related to Target Vessel

    Time frame: During hospitalization

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

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

  41. Number of Participants With MI Related to Target Vessel

    Time frame: 0 to 8 months

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

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

  42. Number of Participants With MI Related to Target Vessel

    Time frame: 0 to 1 year

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

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

  43. Number of Participants With MI Related to Target Vessel

    Time frame: 0 to 2 years

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

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

  44. Number of Participants With MI Related to Target Vessel

    Time frame: 0 to 3 years

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

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

  45. Number of Participants With MI Related to Target Vessel

    Time frame: 0 to 4 years

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

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

  46. Number of Participants With MI Related to Target Vessel

    Time frame: 0 to 5 years

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

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

  47. Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)

    Time frame: During hospitalization

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

  48. Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)

    Time frame: 0 to 8 months

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

  49. Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)

    Time frame: 0 to 1 year

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

  50. Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)

    Time frame: 0 to 2 years

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

  51. Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)

    Time frame: 0 to 3 years

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

  52. Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)

    Time frame: 0 to 4 years

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

  53. Number of Participants With Death,Myocardial Infarction and Revascularization (DMR)

    Time frame: 0 to 5 years

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

  54. Number of Participants With All Revascularization

    Time frame: During hospitalization

    All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

  55. Number of Participants With All Revascularization

    Time frame: 0 to 8 months

    All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

  56. Number of Participants With All Revascularization

    Time frame: 0 to 1 year

    All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

  57. Number of Participants With All Revascularization

    Time frame: 0 to 2 years

    All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

  58. Number of Participants With All Revascularization

    Time frame: 0 to 3 years

    All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

  59. Number of Participants With All Revascularization

    Time frame: 0 to 4 years

    All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

  60. Number of Participants With All Revascularization

    Time frame: 0 to 5 years

    All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

  61. Number of Participants With Target Vessel Failure (TVF)

    Time frame: During hospitalization

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

  62. Number of Participants With Target Vessel Failure (TVF)

    Time frame: 0 to 8 months

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

  63. Number of Participants With Target Vessel Failure (TVF)

    Time frame: 0 to 1 year

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

  64. Number of Participants With Target Vessel Failure (TVF)

    Time frame: 0 to 2 years

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

  65. Number of Participants With Target Vessel Failure (TVF)

    Time frame: 0 to 3 years

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

  66. Number of Participants With Target Vessel Failure (TVF)

    Time frame: 0 to 4 years

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

  67. Number of Participants With Target Vessel Failure (TVF)

    Time frame: 0 to 5 years

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

  68. Number of Participants With Target Vessel Revascularization (Non-TLR)

    Time frame: During hospitalization

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

  69. Number of Participants With Target Vessel Revascularization (Non-TLR)

    Time frame: 0 to 8 months

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

  70. Number of Participants With Target Vessel Revascularization (Non-TLR)

    Time frame: 0 to 1 year

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

  71. Number of Participants With Target Vessel Revascularization (Non-TLR)

    Time frame: 0 to 2 years

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

  72. Number of Participants With Target Vessel Revascularization (Non-TLR)

    Time frame: 0 to 3 years

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

  73. Number of Participants With Target Vessel Revascularization (Non-TLR)

    Time frame: 0 to 4 years

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

  74. Number of Participants With Target Vessel Revascularization (Non-TLR)

    Time frame: 0 to 5 years

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

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

    Time frame: During hospitalization

    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, nonTLR).

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

    Time frame: 0 to 8 months

    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, nonTLR).

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

    Time frame: 0 to 1 year

    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, nonTLR).

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

    Time frame: 0 to 2 years

    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, nonTLR).

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

    Time frame: 0 to 3 years

    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, nonTLR).

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

    Time frame: 0 to 4 years

    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, nonTLR).

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

    Time frame: 0 to 5 years

    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, nonTLR).

  82. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)

    Time frame: During hospitalization

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

  83. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)

    Time frame: 0 to 8 months

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

  84. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)

    Time frame: 0 to 1 year

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

  85. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)

    Time frame: 0 to 2 years

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

  86. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)

    Time frame: 0 to 3 years

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

  87. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)

    Time frame: 0 to 4 years

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

  88. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)

    Time frame: 0 to 5 years

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

  89. Number of Participants With Death/All MI

    Time frame: During hospitalization

    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: Those MIs which are not Q-wave MI

  90. Number of Participants With Death/All MI

    Time frame: 0 to 8 months

    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: Those MIs which are not Q-wave MI

  91. Number of Participants With Death/All MI

    Time frame: 0 to 1 year

    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: Those MIs which are not Q-wave MI

  92. Number of Participants With Death/All MI

    Time frame: 0 to 2 years

    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: Those MIs which are not Q-wave MI

  93. Number of Participants With Death/All MI

    Time frame: 0 to 3 years

    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: Those MIs which are not Q-wave MI

  94. Number of Participants With Death/All MI

    Time frame: 0 to 4 years

    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: Those MIs which are not Q-wave MI

  95. Number of Participants With Death/All MI

    Time frame: 0 to 5 years

    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: Those MIs which are not Q-wave MI

  96. Number of Participants With Cardiac Death/All MI

    Time frame: During hospitalization

    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: Those MIs which are not Q-wave MI

  97. Number of Participants With Cardiac Death/All MI

    Time frame: 0 to 8 months

    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: Those MIs which are not Q-wave MI

  98. Number of Participants With Cardiac Death/All MI

    Time frame: 0 to 1 year

    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: Those MIs which are not Q-wave MI

  99. Number of Participants With Cardiac Death/All MI

    Time frame: 0 to 2 years

    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: Those MIs which are not Q-wave MI

  100. Number of Participants With Cardiac Death/All MI

    Time frame: 0 to 3 years

    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: Those MIs which are not Q-wave MI

  101. Number of Participants With Cardiac Death/All MI

    Time frame: 0 to 4 years

    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: Those MIs which are not Q-wave MI

  102. Number of Participants With Cardiac Death/All MI

    Time frame: 0 to 5 years

    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: Those MIs which are not Q-wave MI

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

    Time frame: During hospitalization

    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).

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

    Time frame: 0 to 8 months

    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).

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

    Time frame: 0 to 1 year

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

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

    Time frame: 0 to 2 years

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

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

    Time frame: 0 to 3 years

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

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

    Time frame: 0 to 4 years

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

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

    Time frame: 0 to 5 years

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

  110. Number of Participants With Target Lesion Failure (TLF)

    Time frame: During hospitalization

    TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  111. Number of Participants With Target Lesion Failure (TLF)

    Time frame: 0 to 8 months

    TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  112. Number of Participants With Target Lesion Failure (TLF)

    Time frame: 0 to 1 year

    TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  113. Number of Participants With Target Lesion Failure (TLF)

    Time frame: 0 to 2 years

    TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  114. Number of Participants With Target Lesion Failure (TLF)

    Time frame: 0 to 3 years

    TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  115. Number of Participants With Target Lesion Failure (TLF)

    Time frame: 0 to 4 years

    TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  116. Number of Participants With Target Lesion Failure (TLF)

    Time frame: 0 to 5 years

    TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  117. Mean Acute Gain: In-stent, In-segment

    Time frame: At 8 months, post index procedure

    The difference between post- and pre-procedural MLD.

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

    Time frame: At 8 months, post index procedure

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

  119. Mean Net Gain: In-stent, In-segment

    Time frame: At 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).

  120. Mean Lesion Length

    Time frame: Pre-procedure

    The lesion length will be measured by QCA.

  121. Minimum Blood Vessel Diameter

    Time frame: Pre-procedure

    Minimum blood vessel diameter measured by QCA

  122. Minimum Blood Vessel Diameter

    Time frame: Immediately after the procedure

    Minimum blood vessel diameter measured by QCA

  123. Minimum Blood Vessel Diameter

    Time frame: During follow-up, at 8 months post procedure

    Minimum blood vessel diameter measured by QCA

  124. Mean Reference Vessel Diameter (RVD)

    Time frame: Pre-procedure

    Reference vessel diameter measured by QCA

  125. Mean Reference Vessel Diameter (RVD)

    Time frame: Immediately after the procedure

    Reference vessel diameter measured by QCA

  126. Mean Reference Vessel Diameter (RVD)

    Time frame: During follow-up, at 8 months post procedure

    Reference vessel diameter measured by QCA

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

XIENCE Xpedition Everolimus-Eluting Coronary Stent Japan Post Marketing Surveillance

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Aug 3, 2015
Registry last updated
May 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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