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The purpose of this registry is to capture clinical data of the BioMatrix™ and BioMatrix Flex™ (Biolimus A9™-Eluting) stent systems in relation to safety and effectiveness.
Prospective, multi-center registry to be conducted at 60-70 international interventional cardiology centers. All patients will be followed for up to 3 years.
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| Measure | Description | Time Frame |
|---|---|---|
| MACE | Major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or justified target vessel revascularization at 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| stent thrombosis | Primary and secondary stent thrombosis (definite and probable according to ARC definitions) at 30 days, 6 and 12 months, 2, 3 and 5 years; | 30 days, 6 and 12 months, 2, 3 and 5 years |
| MACE |
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Inclusion Criteria:
Exclusion Criteria:
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"Real world, all comer" patients
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| Name | Affiliation | Role |
|---|---|---|
| Philip Urban, MD | Hôpital de la Tour | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universität Innsbruck | Innsbruck | Austria | ||||
| AKH der Stadt Wien |
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Major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or justified target vessel revascularization at 30 days, 6 months, 2, 3 and 5 years;
| 30 days, 6 months, 2, 3 and 5 years; |
| Patient Oriented Composite Endpoint defined as any cause mortality, MI (Q-wave and non-Q-wave), or any clinically driven target vessel revascularization at 30 days, 6 and 12 months, 2, 3 and 5 years; | 6 and 12 months, 2, 3 and 5 years |
| Death and MI at 30 days, 6 and 12 months, 2, 3 and 5 years; | 30 days, 6 and 12 months, 2, 3 and 5 years; |
| Death and post-procedural MI at 30 days, 6 and 12 months, 2, 3 and 5 years; | 30 days, 6 and 12 months, 2, 3 and 5 years |
| Total revascularization rate (clinically and non clinically driven) at 30 days, 6 and 12 months, 2, 3 and 5 years. | 30 days, 6 and 12 months, 2, 3 and 5 years. |
| Vienna |
| Austria |
| KFJ - Hospital Vienna | Vienna | Austria |
| Krankenanstalt Rudolfstiftung | Vienna | Austria |
| Teaching Hospital Brno | Brno | Czechia |
| Masaryk Hospital Usti nad Labem | Ústí nad Labem | Czechia |
| Roskilde Sygehus | Roskilde | Denmark |
| Clinique Rhône Durance | Avignon | France |
| Hopital de la Cavale Blanche | Brest | France |
| Hôpital Cardiovasculaire et Pneumologique Louis Pradel | Bron | France |
| CHU Côte de Nacre | Caen | France |
| CMC Parly II | Chesnay | France |
| Centre Hospitalier Henri Mondor | Créteil | France |
| Polyclinique de Bois Bernard | Lille | France |
| Clinique Générale | Marignane | France |
| Centre Hospitalier Privé Beauregard | Marseille | France |
| Institut Hospitalier Jacques Cartier | Massy | France |
| Nouvelles Cliniques Nantaises | Nantes | France |
| Polyclinique Les Fleurs | Ollioules | France |
| Clinique Saint-Hilaire | Rouen | France |
| Hôpital de Rangueil - CHU | Toulouse | France |
| Vivantes Klinikum im Friedrichshain | Berlin | Germany |
| Mater Misericordiae | Dublin | Ireland |
| St. James's Hospital | Dublin | Ireland |
| The Jordan Cardiovascular Center | Amman | Jordan |
| P. Stradins University Hospital | Riga | Latvia |
| Kaunas Univeristy Hospital | Kaunas | Lithuania |
| Clinique Agdal | Rabat | Morocco |
| Hôpital Militaire d'instruction Mohamed-V | Rabat | Morocco |
| Szpital im. J. Strusia | Poznan | Poland |
| Szpital im. Karola Marcinkowskiego | Poznan | Poland |
| Hospital do Espirito Santo | Evora | Portugal |
| Moscow City Hospital | Moscow | Russia |
| St Petersburg | Saint Petersburg | Russia |
| Hospital San Juan de Alicante | Alicante | Spain |
| Hospital Vall d'Hebrón | Barcelona | Spain |
| Hospital Santa Maria del Rosell | Cartagena | Spain |
| Hospital de Galdácano | Galdakao | Spain |
| Hospital Universitario Virgen de la Arrixaca | Murcia | Spain |
| Salamanca Hospital | Salamanca | Spain |
| Hospital Clínico Universitario Santiago | Santiago | Spain |
| Hospital Dr Pesset | Valencia | Spain |
| Hospital General de Valencia | Valencia | Spain |
| Hôpital de la Tour | Meyrin | Canton of Geneva | 1217 | Switzerland |
| Hôpital Cantonal de Fribourg | Fribourg | Switzerland |
| Kantonsspital St.Gallen | Sankt Gallen | Switzerland |
| Triemli Stadtspital | Zurich | Switzerland |
| Universitätsspital Zürich | Zurich | Switzerland |
| Royal United Hospital Bath | Bath | United Kingdom |
| Belfast Health and Social Care TRUST, | Belfast | United Kingdom |
| Blackpool Victoria Hospital | Blackpool | United Kingdom |
| Royal Bournemouth Hospital | Bournemouth | United Kingdom |
| Brighton and Sussex University Hospitals | Brighton | United Kingdom |
| Frenchay Hospital | Bristol | United Kingdom |
| Papworth hospital | Cambridge | United Kingdom |
| Craigavon Cardiac Center | Craigavon | United Kingdom |
| Dorset Country Hospital | Dorchester | United Kingdom |
| Royal Infirmary of Edinburgh | Edinburgh | United Kingdom |
| Golden Jubilee National Hospital | Glasgow | United Kingdom |
| Hairmyres Hospital | Glasgow | United Kingdom |
| Leeds General Infirmary | Leeds | United Kingdom |
| King's College | London | United Kingdom |
| Lister Hospital, London | London | United Kingdom |
| Manchester Royal Infirmary | Manchester | United Kingdom |
| Freeman Hospital | Newcastle | United Kingdom |
| Plymouth Hospitals NHS Trust | Plymouth | United Kingdom |
| Queen Alexandra, Portsmouth | Portsmouth | United Kingdom |
| Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | United Kingdom |
| Royal Wolverhampton Hospitals | Wolverhampton | United Kingdom |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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