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Completed

NCT Number: NCT02513719

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

The objective of the study is to evaluate the safety and efficacy of XIENCE PRIME SV 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 Artery Occlusion Coronary Disease Coronary Occlusion 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

Kimitsu Chuo Hospital, Chiba, 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 PRIME SV Everolimus Eluting 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.

Who can participate

Healthy volunteers accepted: No

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

  • 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.
  • 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 treated (stent delivery system inserted into the body) by XIENCE PRIME SV will be registered (including provisional stenting for side branch treatment but excluding bail-out only use).
  • The observations will be compiled on a per-patient basis even if multiple stents are implanted during the index procedure.
  • A patient whose side-branch is treated by XIENCE PRIME SV can be registered. In such a case, main vessel should be treated by XIENCE PRIME.
  • A patient who are treated by other drug eluting stent (DES) for planned stent and XIENCE PRIME SV for bail-out purpose cannot be registered.
  • 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 PRIME SV and finally treated by other devices only (No XIENCE PRIME SV are implanted) must also be registered. In such a case, only the stent information, device deficiency information and reportable adverse events related to the PRIME stent, if any, are required to be captured. Follow-up of the patient who does not receive any XIENCE PRIME SV stent is not required.
  • A patient may have another lesion(s) that may be treated by larger diameter stent(s). In such a case, treatment by XIENCE PRIME is preferable. Lesion(s) treated by other than XIENCE PRIME is not considered as the target lesion.

Treatment and study plan

XIENCE PRIME SV Everolimus Eluting Coronary Stent

Device

Patients receiving XIENCE PRIME SV Everolimus Eluting Stent

Primary outcomes

  1. Number of Participants With Stent Thrombosis: Acute

    Time frame: 0-24 hours post stent implantation

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

    Timing:

    Acute stent thrombosis: 0 to 24 hours after stent implantation

  2. Number of Participants With Stent Thrombosis: Subacute

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

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

    Timings:

    Subacute stent thrombosis : >24 hours to 30 days after stent implantation

  3. Number of Participants With Stent Thrombosis: Late

    Time frame: 30 days to 1 year post stent implantation

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

    Timings:

    Late stent thrombosis : >30 days to 1 year after stent implantation

Secondary outcomes

  1. Number of Participants With Stent Thrombosis: Very Late

    Time frame: >1 year post stent implantation

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

    Timings:

    Very late stent thrombosis : >1 year after stent implantation.

  2. Percent Diameter Stenosis (%DS)

    Time frame: Pre-procedure

    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).

  3. Percent Diameter Stenosis (%DS)

    Time frame: post procedure (on day 0)

    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).

  4. Percent Diameter Stenosis (%DS)

    Time frame: 8 months

    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).

  5. Success Rate: Percentage of Devices With Implant Success

    Time frame: < or = 1 day

    The stent lengths used were 8 mm, 12 mm, and 15 mm,18 mm, 23 mm, and 28 mm and the stent diameter was 2.25mm.

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

  6. Success Rate: Percentage of Lesions With Procedural Success

    Time frame: < or = 1 day

    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).

  7. Success Rate: XIENCE PRIME Implant Success by Patient

    Time frame: < or = 1 day

    The stent lengths used were 8 mm, 12 mm, and 15 mm,18 mm, 23 mm, and 28 mm and the stent diameter was 2.25 mm.

    Implant success is assessed as per physicians decision, but means that the stent could be implanted at the intended location.

  8. Number of Death

    Time frame: 0 to 8 months

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

  9. Number of 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.

  10. Number of 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.

  11. Number of Death

    Time frame: 0-3 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.

  12. Number of Death

    Time frame: 0-4 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.

  13. Number of Death

    Time frame: 0-５ 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.

  14. 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.

  15. 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.

  16. 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.

  17. Number of Participants With Myocardial Infarction

    Time frame: 0-3 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.

  18. Number of Participants With Myocardial Infarction

    Time frame: 0-4 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.

  19. Number of Participants With Myocardial Infarction

    Time frame: 0-5 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.

  20. Number of Participants With Target Lesion Revascularization

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

  21. Number of Participants With Target Lesion Revascularization

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

  22. Number of Participants With Target Lesion Revascularization

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

  23. Number of Participants With Target Lesion Revascularization

    Time frame: 0-3 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. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR

  24. Number of Participants With Target Lesion Revascularization

    Time frame: 0-4 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. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR

  25. Number of Participants With Target Lesion Revascularization

    Time frame: 0-5 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. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR

  26. 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, non-TLR)

  27. 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, non-TLR)

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

    Time frame: 0 to 2 years

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

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

    Time frame: 0-3 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, non-TLR)

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

    Time frame: 0-4 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, non-TLR)

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

    Time frame: 0-5 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, non-TLR)

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

    Time frame: 0 to 8 months

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

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

    Time frame: 0 to 1 year

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

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

    Time frame: 0 to 2 years

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

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

    Time frame: 0 to 3 years

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

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

    Time frame: 0 to 4 years

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

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

    Time frame: 0 to 5 years

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

  38. Number of Participants With All Revascularization

    Time frame: 0 to 8 months

    Revascularization:

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

  39. Number of Participants With All Revascularization

    Time frame: 0 to 1 year

    Revascularization:

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

  40. Number of Participants With All Revascularization

    Time frame: 0 to 2 years

    Revascularization:

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

  41. Number of Participants With All Revascularization

    Time frame: 0 to 3 years

    Revascularization:

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

  42. Number of Participants With All Revascularization

    Time frame: 0 to 4 years

    Revascularization:

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

  43. Number of Participants With All Revascularization

    Time frame: 0 to 5 years

    Revascularization:

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

  44. Number of Participants With Hemorrhage

    Time frame: 0 to 8 months

    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

  45. Number of Participants With Hemorrhage

    Time frame: 0 to 1 year

    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

  46. Number of Participants With Hemorrhage

    Time frame: 0 to 2 years

    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

  47. Number of Participants With Hemorrhage

    Time frame: 0 to 3 years

    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.

  48. Number of Participants With Hemorrhage

    Time frame: 0 to 4 years

    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.

  49. Number of Participants With Hemorrhage

    Time frame: 0 to 5 years

    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.

  50. Number of Participants With Target Lesion Failure

    Time frame: 0 to 8 months

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

  51. Number of Participants With Target Lesion Failure

    Time frame: 0 to 1 year

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

  52. Number of Participants With Target Lesion Failure

    Time frame: 0 to 2 years

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

  53. Number of Participants With Target Lesion Failure

    Time frame: 0 to 3 years

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

  54. Number of Participants With Target Lesion Failure

    Time frame: 0 to 4 years

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

  55. Number of Participants With Target Lesion Failure

    Time frame: 0 to 5 years

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

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

    Time frame: 0 to 8 months

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

    Time frame: 0 to 1 year

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

    Time frame: 0 to 2 years

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

    Time frame: 0 to 3 years

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

    Time frame: 0 to 4 years

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

    Time frame: 0 to 5 years

  62. Number of Participants With Target Vessel Failure

    Time frame: 0 to 8 months

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

  63. Number of Participants With Target Vessel Failure

    Time frame: 0 to 1 year

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

  64. Number of Participants With Target Vessel Failure

    Time frame: 0 to 2 years

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

  65. Number of Participants With Target Vessel Failure

    Time frame: 0 to 3 years

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

  66. Number of Participants With Target Vessel Failure

    Time frame: 0 to 4 years

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

  67. Number of Participants With Target Vessel Failure

    Time frame: 0 to 5 years

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

  68. Number of Participants With 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 Clinically indicated target lesion revascularization (CI-TLR).

  69. Number of Participants With 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 clinically indicated target lesion revascularization (CI-TLR).

  70. Number of Participants With 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 clinically indicated target lesion revascularization (CI-TLR).

  71. Number of Participants With 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 clinically indicated target lesion revascularization (CI-TLR).

  72. Number of Participants With 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 clinically indicated target lesion revascularization (CI-TLR).

  73. Number of Participants With 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 clinically indicated target lesion revascularization (CI-TLR).

  74. Number of Participants With Death or 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 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.

  75. Number of Participants With Death or 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 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.

  76. Number of Participants With Death or 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 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

  77. Number of Participants With Death or 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 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

  78. Number of Participants With Death or 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 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

  79. Number of Participants With Death or 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 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

  80. Number of Participants With Cardiac Death or 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.)

    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.

  81. Number of Participants With Cardiac Death or 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.) 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.

  82. Number of Participants With Cardiac Death or 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.)

    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.

  83. Number of Participants With Cardiac Death or 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.)

    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.

  84. Number of Participants With Cardiac Death or 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.)

    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.

  85. Number of Participants With Cardiac Death or 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.)

    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.

  86. 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).

  87. 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).

  88. 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).

  89. 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).

  90. 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).

  91. 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).

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

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

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

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

    Time frame: 8 months

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

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

    Time frame: Post-Procedure (on day 0)

    Difference between acute gain and late loss.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

XIENCE PRIME SV Everolimus Eluting Coronary Stent Japan Post Marketing Surveillance

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Aug 3, 2015
Registry last updated
Apr 4, 2024

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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