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| Name | Class |
|---|---|
| European Cardiovascular Research Center | NETWORK |
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Prospective, multi-center, registry designed to enrol up to 2,000 patients in up to 35 International centers. All patients will receive a BioMatrix AlphaTM stent as per clinical practice and will be followed for 2 years for data collection. Major adverse cardiac events (MACE) results at 9 months will be compared to the results obtained from the BioMatrix FlexTM arm of the LEADERS trial.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioMatrix AlphaTM | Device | Cobalt Chromium BA9 TM drug-eluting stent |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or clinically driven target vessel revascularization (TVR). | 9 months |
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Inclusion Criteria:
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diana Schuette | Contact | +447 970 942 022 | d.schuette-consultant@biosensors.com | |
| Abderrahim Kadri | Contact | +33 176 739 210 | akadri@cerc-europe.org |
| Name | Affiliation | Role |
|---|---|---|
| Ian BA Menown, Dr | Craigavon Cardiac Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Craigavon Cardiac Center | Craigavon | United Kingdom |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D060050 | Angina, Stable |
| D007511 | Ischemia |
| D054058 | Acute Coronary Syndrome |
| 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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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| 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 |