Evaluation of Effectiveness and Safety of Bioresorbable Vascular Scaffold in Routine Clinical Practice

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the relative effectiveness and safety of Bioresorbable Vascular Scaffold compared to other (drug eluting stents) DES.

Official Title
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Evaluation of Effectiveness and Safety of Bioresorbable Vascular Scaffold in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Conditions
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Arterial Occlusive Diseases, Cardiovascular Diseases, Coronary Artery Disease, Coronary Disease

Intervention / Treatment
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* Device: Bioresorbable Vascular Scaffold


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 and more Intervention with Bioresorbable Vascular Scaffold Agreed with written informed consent form Exclusion Criteria: Bypass graft surgery (CABG) recommended Lesion with previous bypass graft surgery (CABG) Severe calcification and/or severe tortuosity Contraindication to antiplatelet agent or Inability to take dual antiplatelet therapy within 1 year Life expectancy of 1year and under Subjects scheduled to receive cardiac surgery or serious non-cardiac surgery Cardiac shock

Ages Eligible for Study
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Minimum Age: 19 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 |
| --- | --- |
| Bioresorbable Vascular Scaffold<br> | Device: Bioresorbable Vascular Scaffold<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite event | The number of events with the first occurrence of a composite event(death, non-fatal myocardial infarction, target vessel revascularization) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all death |  | 5 years | 
| cardiac death |  | 5 years | 
| myocardial infarction |  | 5 years | 
| Composite event of death or myocardial infarction |  | 5 years | 
| Composite event of cardiac death or myocardial infarction |  | 5 years | 
| Target Vessel revascularization | 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. Clinical-driven Clinically indicated angiography at follow-up shows a percent diameter stenosis ≥ 50% (core lab QCA assessment) and if one of the following occurs: (1) a positive history of recurrent angina pectoris, presumably related to the target vessel; (2) objective signs of ischemia at rest (ECG changes) of during exercise test (or equivalent), presumably related to the target vessel; (3) abnormal results of any invasive functional diagnostic test (eg, Doppler flow velocity reserve, fractional flow reserve). Ischemia-driven if one of followings of above-mentioned symptom (clinical-driven) or sign of ischemia or diameter stenosis ≥ 70 % | 5 years | 
| Target Lesion revascularization | 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 TLRs should be classified prospectively as clinically indicated 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 stent. | 5 years | 
| Stent thrombosis | DEFINITE stent thrombosis : acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE stent thrombosis : unexplained death within 30 days or target-vessel infarction without angiographic information Academic Research Consortium (ARC) stent thrombosis is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute stent thrombosis: 0-24 hours after stent implantation; Subacute stent thrombosis: >24 hours to 30 days post; late stent thrombosis: >30 days to 1 year post; Very late stent thrombosis: >1 year post; | 5 years | 
| Stroke |  | 5 years | 
| Procedural success | Defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioresorbable Vascular Scaffold, Routine Clinical Practice, Angioplasty, Transluminal, Percutaneous Coronary, Coronary Artery Disease, drug eluting stent