e-BioMatrix 6 Month DAPT France

Study Overview
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Brief Summary
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Prospective, multi-center observational study to be conducted in up to 30 French interventional cardiology centers. The purpose of this observational study is to capture, in French Centers, clinical data of the BioMatrix Flex™ and BioMatrix NeoFlex™ Drug Eluting Coronary Stents System (Biolimus A9, BA9™-) in normal practice, in patients treated with 6-month DAPT, and to compare the outcomes to those of previous e-biomatrix registries with longer DAPT durations. The patients will be followed up for 2 years for data collection.

Official Title
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A French Post-market Observational/Non-interventional Study of the BioMatrix Flex™ and BioMatrix Neo Flex™ Drug Eluting Stents With 6-month DAPT

Conditions
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Coronary Artery Stenoses, Stable Angina, Ischemia, NSTEMI - Non-ST Segment Elevation MI, STEMI

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Real world, all comer patients Age ≥18 years; Patients that need a treatment with a BioMatrix Flex™ drug- eluting stent or a BioMatrix NeoFlex™drug-eluting stent; Presence of one or more coronary artery stenoses in a native coronary artery from 2.25 to 4.0 mm in diameter that can be covered with one or multiple stents; No limitation on the number of treated lesions, vessels, and lesion length, within the limits of social security reimbursements; Patient with DAPT indication after PCI. Exclusion Criteria: Inability to provide informed consent; Patients needing additional stent NOT of the BioMatrix Flex™ or NeoFlex™ types; Patients receiving next to the BioMatrix Flex™ or BioMatrix NeoFlex™ also other coronary vascular interventions, for example, balloon dilation; Pregnant or planning to become pregnant patient; DES and BMS implantation less than 6 months before screening;

Ages Eligible for Study
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Minimum Age: 18 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac and cerebrovascular events (MACCE) in the overall population, defined as composite of all-cause death, cerebrovascular accidents, non fatal myocardial infarction or clinically-driven target vessel revascularization at 6 months | Major adverse cardiac and cerebrovascular events (MACCE) in the overall population, defined as composite of all-cause death, cerebrovascular accidents, non fatal myocardial infarction or clinically-driven target vessel revascularization at 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary and secondary stent thrombosis | Primary and secondary stent thrombosis (definite and probable according to ARC definitions) at 6 months and 2 years; | 6 months and 2 years | 
| Major bleeding | Major bleeding (BARC 3, 4 and 5 definitions) at 6 months and 2 years | 6 months and 2 years | 
| Major adverse cardiac and cerebrovascular events (MACCEs) in the overall population | Major adverse cardiac and cerebrovascular events (MACCEs) in the overall population, defined as composite of all cause death, myocardial infarction (Q-wave and non-Q-wave), cerebrovascular accidents or clinically-driven target vessel revascularization at 2 years | 2 years | 
| Cardiac deaths at 6 months and and 2 years | Cardiac deaths at 6 months and and 2 years | 6 months and and 2 years | 
| Patient Oriented Composite Endpoint defined as any cause mortality, MI (Q-wave and non-Q-wave), or any revascularization at 6 months and 2 years | Patient Oriented Composite Endpoint defined as any cause mortality, MI (Q-wave and non-Q-wave), or any revascularization at 6 months and 2 years | 6 months and 2 years | 
| Death,MI and cerebrovascular accidents at 6 months and 2 years | Death,MI and cerebrovascular accidents at 6 months and 2 years | 6 months and 2 years | 
| Death, post-procedural MI and cerebrovascular accidents at 6 months and 2 years | Death, post-procedural MI and cerebrovascular accidents at 6 months and 2 years | 6 months and 2 years |