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| Name | Class |
|---|---|
| European Cardiovascular Research Center | NETWORK |
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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 Flexâ„¢ and BioMatrix NeoFlexâ„¢ Drug Eluting Coronary Stents System (Biolimus A9, BA9â„¢-) 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.
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| 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 |
| 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 |
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Inclusion Criteria:
"Real world, all comer" patients
Exclusion Criteria:
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"Real world, all comers" patient population: Patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions and can be treated with 6-month DAPT
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| Name | Affiliation | Role |
|---|---|---|
| Christian Spaulding, MD | Hôpital Européen Georges-Pompidou | Principal Investigator |
| Lanusz Lipiecki, MD | Clinique des Dômes | Principal Investigator |
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| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| D060050 | Angina, Stable |
| D007511 | Ischemia |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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 |
| D014652 |
| Vascular Diseases |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D009336 | Necrosis |