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OpenTrials
Completed

NCT Number: NCT01721096

XIENCE PRIME Japan Post-Marketing Surveillance (PMS)

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with ischemic heart disease who are eligible for treatment with XIENCE PRIME Everolimus Eluting Stent
  • Patient provides Informed Consent Form

Exclusion criteria

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

Treatment and study plan

XIENCE PRIME - Long Length (LL)

Device

Long Length

XIENCE PRIME - Core Size

Device

Core Size

Primary outcomes

  1. Number of Participants With Acute Stent Thrombosis (ST)

    Time frame: Time Frame: Acute (0-24 hours)

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

  2. Number of Participants With Subacute Stent Thrombosis (ST)

    Time frame: Subacute (>24 hours to 30 days)

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

  3. Number of Participants With Late Stent Thrombosis (ST)

    Time frame: Late (>30 days to 1 year)

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

  4. Total Number of Participants With Overall Stent Thrombosis

    Time frame: 1 year post index procedure

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

Secondary outcomes

  1. Success Rate: Percentage of Participants With Implant Success Rate by Device

    Time frame: Participants will be followed for the duration of hospital stay, an average of 5 days

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

  2. Success Rate: Percentage of Participants With Procedural Success by Lesion

    Time frame: Participants will be followed for the duration of hospital stay, an average of 5 days

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

  3. Success Rate: Percentage of Participants With Clinical Success by Patient (Per Patient Base)

    Time frame: Participants will be followed for the duration of hospital stay, an average of 5 days

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

    Time frame: 8 months post index procedure

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

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

    Time frame: 1 year post index procedure

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

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

    Time frame: 2 year post index procedure

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

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

    Time frame: 3 years post index procedure

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

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

    Time frame: 4 year post index procedure

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

  9. Number of Participants With All Death/All MI/All Revascularization (DMR)

    Time frame: 8 months post index procedure

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

  10. Number of Participants With All Death/All MI/All Revascularization (DMR)

    Time frame: 1 year post index procedure

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

  11. Number of Participants With All Death/All MI/All Revascularization (DMR)

    Time frame: 2 year post index procedure

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

  12. Number of Participants With All Death/All MI/All Revascularization (DMR)

    Time frame: 3 year post index procedure

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

  13. Number of Participants With All Death/All MI/All Revascularization (DMR)

    Time frame: 4 year post index procedure

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

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

    Time frame: 8 months post index procedure

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

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

    Time frame: 1 year post index procedure

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

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

    Time frame: 2 year post index procedure

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

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

    Time frame: 3 year post index procedure

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

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

    Time frame: 4 year post index procedure

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

  19. Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)

    Time frame: 8 months post index procedure

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

  20. Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)

    Time frame: 1 year post index procedure

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

  21. Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)

    Time frame: 2 year post index procedure

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

  22. Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)

    Time frame: 3 year post index procedure

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

  23. Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)

    Time frame: 4 year post index procedure

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

  24. Number of Participants With Death or Myocardial Infarction (MI)

    Time frame: 8 months post index procedure

    All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

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

    Non-Q wave MI: Those MIs which are not Q-wave MI

  25. Number of Participants With Death or Myocardial Infarction (MI)

    Time frame: 1 year post index procedure

    All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

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

    Non-Q wave MI: Those MIs which are not Q-wave MI

  26. Number of Participants With Death or Myocardial Infarction (MI)

    Time frame: 2 year post index procedure

    All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

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

    Non-Q wave MI: Those MIs which are not Q-wave MI

  27. Number of Participants With Death or Myocardial Infarction (MI)

    Time frame: 3 year post index procedure

    All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

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

    Non-Q wave MI: Those MIs which are not Q-wave MI

  28. Number of Participants With Death or Myocardial Infarction (MI)

    Time frame: 4 year post index procedure

    All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.

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

    Non-Q wave MI: Those MIs which are not Q-wave MI

  29. Number of Participants With Cardiac Death or Myocardial Infarction (MI)

    Time frame: 8 months post index procedure

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

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

  30. Number of Participants With Cardiac Death or Myocardial Infarction (MI)

    Time frame: 1 year post index procedure

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

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

  31. Number of Participants With Cardiac Death or Myocardial Infarction (MI)

    Time frame: 2 year post index procedure

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

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

  32. Number of Participants With Cardiac Death or Myocardial Infarction (MI)

    Time frame: 3 year post index procedure

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

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

  33. Number of Participants With Cardiac Death or Myocardial Infarction (MI)

    Time frame: 4 year post index procedure

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

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

  34. Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)

    Time frame: 8 months post index procedure

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

    TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction.

  35. Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)

    Time frame: 1 year post index procedure

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

    TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction.

  36. Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)

    Time frame: 2 year post index procedure

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

    TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction.

  37. Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)

    Time frame: 3 year post index procedure

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

    TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction.

  38. Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)

    Time frame: 4 year post index procedure

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

    TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction.

  39. Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)

    Time frame: 8 months post index procedure

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma

  40. Number of of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)

    Time frame: 1 year post index procedure

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma

  41. Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)

    Time frame: 2 year post index procedure

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma

  42. Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)

    Time frame: 3 year post index procedure

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma

  43. Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)

    Time frame: 4 year post index procedure

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma

  44. Number of Participants With Myocardial Infarction (MI)

    Time frame: 8 months post index procedure

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

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

  45. Number of Participants With Myocardial Infarction (MI)

    Time frame: 1 year post index procedure

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

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

  46. Number of Participants With Myocardial Infarction (MI)

    Time frame: 2 year post index procedure

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

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

  47. Number of Participants With Myocardial Infarction (MI)

    Time frame: 3 year post index procedure

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

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

  48. Number of Participants With Myocardial Infarction (MI)

    Time frame: 4 year post index procedure

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

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

  49. Number of Participants With Target Lesion Revascularization (TLR)

    Time frame: 8 months post index procedure

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

    Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.

  50. Number of Participants With Target Lesion Revascularization (TLR)

    Time frame: 1 year post index procedure

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

    Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.

  51. Number of Participants With Target Lesion Revascularization (TLR)

    Time frame: 2 year post index procedure

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

    Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.

  52. Number of Participants With Target Lesion Revascularization (TLR)

    Time frame: 3 year post index procedure

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

    Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.

  53. Number of Participants With Target Lesion Revascularization(TLR)

    Time frame: 4 year post index procedure

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

    Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.

  54. Number of Participants With Non-Target Lesion Revascularization (Non-TLR)

    Time frame: 8 months post index procedure

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

  55. Number of Participants With Non-Target Lesion Revascularization (Non-TLR)

    Time frame: 1 year post index procedure

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

  56. Number of Participants With Non-Target Lesion Revascularization (Non-TLR)

    Time frame: 2 year post index procedure

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

  57. Number of Participants With Non-Target Lesion Revascularization (Non-TLR)

    Time frame: 3 year post index procedure

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

  58. Number of Participants With Non-Target Lesion Revascularization (Non-TLR)

    Time frame: 4 year post index procedure

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

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

    Time frame: 8 months post index procedure

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

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

    Time frame: 1 year post index procedure

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

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

    Time frame: 2 year post index procedure

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

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

    Time frame: 3 year post index procedure

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

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

    Time frame: 4 year post index procedure

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

  64. Number of Participants With Non-Target Vessel Revascularization (Non-TVR)

    Time frame: 8 months post index procedure

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

  65. Number of Participants With Non-Target Vessel Revascularization (Non-TVR)

    Time frame: 1 year post index procedure

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

  66. Number of Participants With Non-Target Vessel Revascularization (Non-TVR)

    Time frame: 2 year post index procedure

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

  67. Number of Participants With Non-Target Vessel Revascularization (Non-TVR)

    Time frame: 3 year post index procedure

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

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

    Time frame: 4 year post index procedure

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

  69. Number of Participants With All Revascularization

    Time frame: 8 months post index procedure

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

  70. Number of Participants With All Revascularization

    Time frame: 1 year post index procedure

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

  71. Number of Participants With All Revascularization

    Time frame: 2 year post index procedure

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

  72. Number of Participants With All Revascularization

    Time frame: 3 year post index procedure

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

  73. Number of Participants With All Revascularization

    Time frame: 4 year post index procedure

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

  74. Number of Participants Experienced Bleeding

    Time frame: 8 months post index procedure

    Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.

    Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding

  75. Number of Participants Experienced Bleeding

    Time frame: 1 year post index procedure

    Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.

    Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding

  76. Number of Participants Experienced Bleeding

    Time frame: 2 year post index procedure

    Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.

    Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding

  77. Number of Participants Experienced Bleeding

    Time frame: 3 year post index procedure

    Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.

    Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding

  78. Number of Participants Experienced Bleeding

    Time frame: 4 year post index procedure

    Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.

    Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding

  79. Percent Diameter Stenosis (%DS)

    Time frame: Baseline

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

  80. Percent Diameter Stenosis (%DS)

    Time frame: Post procedure

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

  81. Percent Diameter Stenosis (%DS)

    Time frame: 8 months post index procedure

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

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

    Time frame: 8 months post index procedure

    The difference between post- and pre-procedural MLD.

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

    Time frame: 8 months post index procedure

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

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

    Time frame: 8 months post index procedure

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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2018
First posted
Nov 5, 2012
Registry last updated
Dec 20, 2019

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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