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

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

Detailed Description
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Based on Good Post-marketing Study Practice (GPSP) regulation, general patient population with ischemic heart disease who are eligible for treatment with XIENCE Xpedition Everolimus-Eluting 2.25mm Stent will be registered, with no particular inclusion/exclusion criteria, and may be eligible for angiographic follow-up at eight months and clinical follow-up at one year. The XIENCE Xpedition 2.25 mm stent is composed of the stent identical to the stent of the XIENCE PRIME SV Stent.Therefore, the data collected from the PMS will be pooled with data collected from the ongoing XIENCE PRIME SV PMS for analysis.

Official Title
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XIENCE Xpedition Everolimus-Eluting Coronary Stent Japan Post Marketing Surveillance

Conditions
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Ischemic Heart Disease, Angina Pectoris, Coronary Artery Disease, Myocardial Ischemia

Intervention / Treatment
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* Device: XIENCE Xpedition 2.25 mm stent


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Patient informed consent is required for registration of this PMS. In cases where patient informed consent (or providing some type of information) is required for PMS per the participating site policy, the Sponsor will cooperate as needed. Patients who are treated by XIENCE Xpedition 2.25mm stent will be registered. The observations will be compiled on a per-patient basis even if multiple XIENCE Xpedition 2.25mm stents are implanted during the index procedure. A patient whose side-branch is treated by XIENCE Xpedition 2.25mm stent can be registered. In such a case, main vessel should be treated by XIENCE Xpedition. The observations will not be compiled on a per-patient basis if a patient is treated by XIENCE Xpedition 2.25mm stent overlapped with other stents for bail-out purpose. Additional revascularization procedures as a part of adverse event treatment and planned staged procedures will not be considered as another registration, or adverse events. A patient who is treated, but failed to be implanted by XIENCE Xpedition 2.25mm stent and finally treated by other devices only (No XIENCE Xpedition 2.25mm stent are implanted) must also be registered. In such a case, only the stent information, device deficiency information and reportable adverse events related to the Xpedition stent, if any, are required to be captured. Follow-up of the patient who does not receive any XIENCE Xpedition 2.25mm stent is not required. Exclusion criteria If it is known at the time of index procedure that the patient is not able to return for the 8-month follow-up visit for angiogram and for the 1-year clinical follow-up, then the patient should not be registered in the PMS. Patients who are attending or will attend other PMS with invasive medical procedure will not be registered. A patient may have another lesion(s) that may be treated by larger diameter (≥ 2.5mm) stent(s). In such a case, treatment by XIENCE Xpedition is preferable. Lesion(s) treated by other than XIENCE Xpedition 2.25mm stent is not considered as the target lesion.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| XIENCE Xpedition 2.25 mm stent arm<br>Patients receiving XIENCE Xpedition 2.25 mm stent | Device: XIENCE Xpedition 2.25 mm stent<br>* Patients receiving XIENCE Xpedition 2.25 mm stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Stent Thrombosis: Late | Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation | 30 days to 1 year post stent implantation-Day 212 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Diameter Stenosis (%DS) | In-segment, In-stent, Proximal and Distal. The value calculated as 100 * (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). | Pre-procedure | 
| Percent Diameter Stenosis (%DS) | In-segment, In-stent, Proximal and Distal. The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). | Immediately after the procedure | 
| Percent Diameter Stenosis (%DS) | In-segment, In-stent, Proximal and Distal. The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). | During follow-up, at 8 months post procedure | 
| Number of Participants Using Antiplatelet Therapy | Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents. | At baseline before procedure | 
| Number of Participants Using Antiplatelet Therapy | Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents. | Date of discharge from procedure day | 
| Number of Participants Using Antiplatelet Therapy | Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents. | 8 months observation day from the procedure day | 
| Number of Participants Using Antiplatelet Therapy | Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents. | 1 year observation day from the procedure day | 
| Number of Participants Using Antiplatelet Therapy | Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents. | 2 years observation day from the procedure day | 
| Number of Participants Using Antiplatelet Therapy | Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents. | 3 years observation day from the procedure day | 
| Number of Participants Using Antiplatelet Therapy | Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents. | 4 years observation day from the procedure day | 
| Number of Participants Using Antiplatelet Therapy | Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents. | 5 years observation day from the procedure day | 
| Number of Participants With Death | All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | During hospitalization | 
| Number of Participants With Death | All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | 0 to 8 months | 
| Number of Participants With Death | All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | 0 to 1 year | 
| Number of Participants With Death | All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | 0 to 2 years | 
| Number of Participants With Death | All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | 0 to 3 years | 
| Number of Participants With Death | All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | 0 to 4 years | 
| Number of Participants With Death | All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | 0 to 5 years | 
| Number of Participants With Target Lesion Revascularization Based on Ischemia Findings | 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. | During hospitalization | 
| Number of Participants With Target Lesion Revascularization Based on Ischemia Findings | 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. | 0 to 8 months | 
| Number of Participants With Target Lesion Revascularization Based on Ischemia Findings | 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. | 0 to 1 year | 
| Number of Participants With Target Lesion Revascularization Based on Ischemia Findings | 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. | 0 to 2 years | 
| Number of Participants With Target Lesion Revascularization Based on Ischemia Findings | 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. | 0 to 3 years | 
| Number of Participants With Target Lesion Revascularization Based on Ischemia Findings | 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. | 0 to 4 years | 
| Number of Participants With Target Lesion Revascularization Based on Ischemia Findings | 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. | 0 to 5 years | 
| Number of Participants With Myocardial Infarction | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | During hospitalization | 
| Number of Participants With Myocardial Infarction | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves | 0 to 8 months | 
| Number of Participants With Myocardial Infarction | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves | 0 to 1 year | 
| Number of Participants With Myocardial Infarction | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves | 0 to 2 years | 
| Number of Participants With Myocardial Infarction | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves | 0 to 3 years | 
| Number of Participants With Myocardial Infarction | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves | 0 to 4 years | 
| Number of Participants With Myocardial Infarction | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves | 0 to 5 years | 
| Number of Participants With Cardiac Death | 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.) | During hospitalization | 
| Number of Participants With Cardiac Death | 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.) | 0 to 8 months | 
| Number of Participants With Cardiac Death | 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.) | 0 to 1 year | 
| Number of Participants With Cardiac Death | 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.) | 0 to 2 years | 
| Number of Participants With Cardiac Death | 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.) | 0 to 3 Years | 
| Number of Participants With Cardiac Death | 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.) | 0 to 4 years | 
| Number of Participants With Cardiac Death | 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.) | 0 to 5 years | 
| Number of Participants With MI Related to Target Vessel | 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 | During hospitalization | 
| Number of Participants With MI Related to Target Vessel | 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 | 0 to 8 months | 
| Number of Participants With MI Related to Target Vessel | 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 | 0 to 1 year | 
| Number of Participants With MI Related to Target Vessel | 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 | 0 to 2 years | 
| Number of Participants With MI Related to Target Vessel | 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 | 0 to 3 years | 
| Number of Participants With MI Related to Target Vessel | 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 | 0 to 4 years | 
| Number of Participants With MI Related to Target Vessel | 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 | 0 to 5 years | 
| Number of Participants With Death,Myocardial Infarction and Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization. | During hospitalization | 
| Number of Participants With Death,Myocardial Infarction and Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization. | 0 to 8 months | 
| Number of Participants With Death,Myocardial Infarction and Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization. | 0 to 1 year | 
| Number of Participants With Death,Myocardial Infarction and Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization. | 0 to 2 years | 
| Number of Participants With Death,Myocardial Infarction and Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization. | 0 to 3 years | 
| Number of Participants With Death,Myocardial Infarction and Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization. | 0 to 4 years | 
| Number of Participants With Death,Myocardial Infarction and Revascularization (DMR) | DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization. | 0 to 5 years | 
| Number of Participants With All Revascularization | All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR. | During hospitalization | 
| Number of Participants With All Revascularization | All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR. | 0 to 8 months | 
| Number of Participants With All Revascularization | All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR. | 0 to 1 year | 
| Number of Participants With All Revascularization | All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR. | 0 to 2 years | 
| Number of Participants With All Revascularization | All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR. | 0 to 3 years | 
| Number of Participants With All Revascularization | All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR. | 0 to 4 years | 
| Number of Participants With All Revascularization | All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR. | 0 to 5 years | 
| Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | During hospitalization | 
| Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | 0 to 8 months | 
| Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | 0 to 1 year | 
| Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | 0 to 2 years | 
| Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | 0 to 3 years | 
| Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | 0 to 4 years | 
| Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR). | 0 to 5 years | 
| Number of Participants With Target Vessel Revascularization (Non-TLR) | Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR. | During hospitalization | 
| Number of Participants With Target Vessel Revascularization (Non-TLR) | Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR. | 0 to 8 months | 
| Number of Participants With Target Vessel Revascularization (Non-TLR) | Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR. | 0 to 1 year | 
| Number of Participants With Target Vessel Revascularization (Non-TLR) | Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR. | 0 to 2 years | 
| Number of Participants With Target Vessel Revascularization (Non-TLR) | Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR. | 0 to 3 years | 
| Number of Participants With Target Vessel Revascularization (Non-TLR) | Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR. | 0 to 4 years | 
| Number of Participants With Target Vessel Revascularization (Non-TLR) | Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR. | 0 to 5 years | 
| Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) | Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR). | During hospitalization | 
| Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) | Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR). | 0 to 8 months | 
| Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) | Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR). | 0 to 1 year | 
| Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) | Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR). | 0 to 2 years | 
| Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) | Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR). | 0 to 3 years | 
| Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) | Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR). | 0 to 4 years | 
| Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR)) | Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR). | 0 to 5 years | 
| Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). | During hospitalization | 
| Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). | 0 to 8 months | 
| Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). | 0 to 1 year | 
| Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). | 0 to 2 years | 
| Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). | 0 to 3 years | 
| Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). | 0 to 4 years | 
| Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) | Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR). | 0 to 5 years | 
| Number of Participants With Death/All MI | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI | During hospitalization | 
| Number of Participants With Death/All MI | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI | 0 to 8 months | 
| Number of Participants With Death/All MI | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI | 0 to 1 year | 
| Number of Participants With Death/All MI | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI | 0 to 2 years | 
| Number of Participants With Death/All MI | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI | 0 to 3 years | 
| Number of Participants With Death/All MI | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI | 0 to 4 years | 
| Number of Participants With Death/All MI | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI | 0 to 5 years | 
| Number of Participants With Cardiac Death/All MI | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI | During hospitalization | 
| Number of Participants With Cardiac Death/All MI | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI | 0 to 8 months | 
| Number of Participants With Cardiac Death/All MI | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI | 0 to 1 year | 
| Number of Participants With Cardiac Death/All MI | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI | 0 to 2 years | 
| Number of Participants With Cardiac Death/All MI | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI | 0 to 3 years | 
| Number of Participants With Cardiac Death/All MI | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI | 0 to 4 years | 
| Number of Participants With Cardiac Death/All MI | All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI | 0 to 5 years | 
| Number of Participants With Cardiac Death or Target-Vessel MI | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). | During hospitalization | 
| Number of Participants With Cardiac Death or Target-Vessel MI | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). | 0 to 8 months | 
| Number of Participants With Cardiac Death or Target-Vessel MI | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). | 0 to 1 year | 
| Number of Participants With Cardiac Death or Target-Vessel MI | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). | 0 to 2 years | 
| Number of Participants With Cardiac Death or Target-Vessel MI | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). | 0 to 3 years | 
| Number of Participants With Cardiac Death or Target-Vessel MI | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). | 0 to 4 years | 
| Number of Participants With Cardiac Death or Target-Vessel MI | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). | 0 to 5 years | 
| Number of Participants With Target Lesion Failure (TLF) | TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR). | During hospitalization | 
| Number of Participants With Target Lesion Failure (TLF) | TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR). | 0 to 8 months | 
| Number of Participants With Target Lesion Failure (TLF) | TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR). | 0 to 1 year | 
| Number of Participants With Target Lesion Failure (TLF) | TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR). | 0 to 2 years | 
| Number of Participants With Target Lesion Failure (TLF) | TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR). | 0 to 3 years | 
| Number of Participants With Target Lesion Failure (TLF) | TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR). | 0 to 4 years | 
| Number of Participants With Target Lesion Failure (TLF) | TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR). | 0 to 5 years | 
| Mean Acute Gain: In-stent, In-segment | The difference between post- and pre-procedural MLD. | At 8 months, post index procedure | 
| Mean Late Loss(LL): In-stent, In-segment, Proximal, and Distal | Late loss is calculated as MLD post procedure - MLD at follow-up. | At 8 months, post index procedure | 
| Mean Net Gain: In-stent, In-segment | 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). | At 8 months, post index procedure | 
| Mean Lesion Length | The lesion length will be measured by QCA. | Pre-procedure | 
| Minimum Blood Vessel Diameter | Minimum blood vessel diameter measured by QCA | Pre-procedure | 
| Minimum Blood Vessel Diameter | Minimum blood vessel diameter measured by QCA | Immediately after the procedure | 
| Minimum Blood Vessel Diameter | Minimum blood vessel diameter measured by QCA | During follow-up, at 8 months post procedure | 
| Mean Reference Vessel Diameter (RVD) | Reference vessel diameter measured by QCA | Pre-procedure | 
| Mean Reference Vessel Diameter (RVD) | Reference vessel diameter measured by QCA | Immediately after the procedure | 
| Mean Reference Vessel Diameter (RVD) | Reference vessel diameter measured by QCA | During follow-up, at 8 months post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Eluting Stent, Coronary Stent, Everolimus, Stent Thrombosis