XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan

Study Overview
=================
Brief Summary
-----------------
The objectives of this post-marketing surveillance, conducted in Japan, is to know the frequency, type and degree of device malfunction, to assure the safety of the medical device, and to collect information on evaluation of the efficacy and safety.

Detailed Description
-----------------
The surveillance is to be conducted in accordance with the Japanese Ministerial Ordinance concerning the Standards for Postmarketing Surveillance and Tests of Medical Devices.

Official Title
-----------------
XIENCE V/PROMUS Everolimus-Eluting Stent System Japan Post-marketing Surveillance Protocol

Conditions
-----------------
Angina, Chronic Coronary Occlusion, Stent Thrombosis, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis

Intervention / Treatment
-----------------
* Device: XIENCE V / PROMUS stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only XIENCE V stent(s)or PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure. Exclusion Criteria: Neither XIENCE V stent(s) nor PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| XIENCE V / PROMUS stent<br>Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed. | Device: XIENCE V / PROMUS stent<br>* Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Stent Thrombosis (ST) as Per ARC Definition | Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. Probable ST may occur due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause. Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up | Post Procedure to 1 Year | 
| Number of Participants With Stent Thrombosis (ST) as Per ARC Definition | Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. Probable ST may occur due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause. Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up | From 1 Year to 2 Years | 
| Number of Participants With Stent Thrombosis (ST) as Per ARC Definition | Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. Probable ST may occur due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause. Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up | From 2 years to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events Related to Anti-platelet Medication |  | From post-procedure to 1 year | 
| Number of Participants With Adverse Events Related to Anti-platelet Medication |  | From 1 year to 2 years | 
| Number of Participants With Adverse Events Related to Anti-platelet Medication |  | From 2 years to 3 years | 
| Number of Participants With Adverse Events Related to Anti-platelet Medication |  | From 3 years to 4 years | 
| Number of Participants With Adverse Events Related to Anti-platelet Medication |  | From 4 years to 5 years | 
| Percent Diameter Stenosis (%DS) | Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). | Baseline | 
| Percent Diameter Stenosis (%DS) | Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). | On day 0 after procedure | 
| Percent Diameter Stenosis (%DS) | Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). | At 8 months | 
| Acute Gain | The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD). | On day 0 after procedure | 
| Late Loss | Proximal and distal late loss was calculated by [post-procedure minimum lumen diameter (MLD)] - [MLD at 8 months]. | On day 0 after procedure | 
| Net Gain | Net Gain = Acute Gain - Late Loss, paired analysis only. | On day 0 after procedure | 
| Acute Success | Acute Success: Procedural Success (Subject Level Analysis): Stent implant procedure was considered successful when all of the following criteria were met: Stent was successfully delivered to the intended location Stent was successfully deployed at the intended location Stent delivery system was withdrawn without any issue Stent implantation procedure was considered successful in 99.94% of the stents. There was no stent adjudicated as procedure failure. | On day 0 (Immediately post-index procedure) | 
| Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular 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. | Post Procedure to 1 Year | 
| Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular 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. | From 1 to 2 years | 
| Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular 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. | From 2 years to 3 years | 
| Number of Participants With Myocardial Infarctions (MI) | 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. | Post Procedure to 1 Year | 
| Number of Participants With Myocardial Infarctions (MI) | 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. | From 1 year to 2 years | 
| Number of Participants With Myocardial Infarctions (MI) | 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. | From 2 years to 3 years | 
| Number of Participants With Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | Post Procedure to 1 Year | 
| Number of Participants With Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | From 1 year to 2 years | 
| Number of Participants With Target Lesion Revascularization (TLR) | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. | From 2 years to 3 years | 
| Number of Participants With Target Vessel Revascularization (TVR) | Target Vessel Revascularization 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 which includes upstream and downstream branches and the target lesion itself. | Post Procedure to 1 Year | 
| Number of Participants With Target Vessel Revascularization (TVR) | Target Vessel Revascularization 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 which includes upstream and downstream branches and the target lesion itself. | From 1 Year to 2 Years | 
| Number of Participants With Target Vessel Revascularization (TVR) | Target Vessel Revascularization 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 which includes upstream and downstream branches and the target lesion itself. | From 2 Years to 3 Years | 
| Number of Participants With Cardiac Death and All MI | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | Post Procedure to 1 Year | 
| Number of Participants With Cardiac Death and All MI | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | From 1 Year to 2 Years | 
| Number of Participants With Cardiac Death and All MI | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. | From 2 Years to 3 Years | 
| Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR) |  | Post Procedure to 1 Year | 
| Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR) |  | From 1 Year to 2 Years | 
| Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR) |  | From 2 Years to 3 Years | 
| Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR |  | Post Procedure to 1 Year | 
| Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR |  | From 1 Year to 2 Years | 
| Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR |  | From 2 Years to 3 Years | 
| Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR) |  | Post Procedure to 1 Year | 
| Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR) |  | From 1 Year to 2 Years | 
| Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR) |  | From 2 Years to 3 Years | 
| Number of Participants With All Deaths and All MI |  | Post Procedure to 1 Year | 
| Number of Participants With All Deaths and All MI |  | From 1 Year to 2 Years | 
| Number of Participants With All Deaths and All MI |  | From 2 Years to 3 Years | 
| Number of Participants With All Deaths, All MI and All Revascularization |  | Post Procedure to 1 Year | 
| Number of Participants With All Deaths, All MI and All Revascularization |  | From 1 Year to 2 Years | 
| Number of Participants With All Deaths, All MI and All Revascularization |  | From 2 Years to 3 Years | 
| Number of Participants With All Deaths, TVMI and TLR |  | Post Procedure to 1 Year | 
| Number of Participants With All Deaths, TVMI and TLR |  | From 1 Year to 2 Years | 
| Number of Participants With All Deaths, TVMI and TLR |  | From 2 Years to 3 Years | 
| Number of Participants With All Deaths, TVMI and CI-TLR |  | Post Procedure to 1 Year | 
| Number of Participants With All Deaths, TVMI and CI-TLR |  | From 1 Year to 2 Years | 
| Number of Participants With All Deaths, TVMI and CI-TLR |  | From 2 Years to 3 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug eluting stents, Stents, Angioplasty