e-BioMatrix PostMarket Registry
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT01289002
- Lead Sponsor
- Biosensors Europe SA
- Brief Summary
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.
- Detailed Description
Prospective, multi-center registry to be conducted at 60-70 international interventional cardiology centers. All patients will be followed for up to 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5652
- Age ≥18 years
- Patients that need a treatment with either a BioMatrix™ or a BioMatrix Flex™ drug-eluting stent
- Presence of one or more coronary artery stenoses in a native coronary artery or a saphenous bypass graft 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, and vessels, and lesion length
- Inability to provide informed consent
- Patients needing additional stent NOT of the Biolimus A9™-eluting stent type
- Patients receiving next to the Biolimus A9™-eluting stent also other coronary vascular interventions, for example dilation
- Patients receiving both the BioMatrix™ and the BioMatrix Flex™ stent during index and/or staged procedure
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MACE 12 months 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.
- Secondary Outcome Measures
Name Time Method 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 MACE 30 days, 6 months, 2, 3 and 5 years; 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;
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; stent thrombosis 30 days, 6 and 12 months, 2, 3 and 5 years Primary and secondary stent thrombosis (definite and probable according to ARC definitions) at 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. 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
Trial Locations
- Locations (69)
Craigavon Cardiac Center
🇬🇧Craigavon, United Kingdom
Hospital do Espirito Santo
🇵🇹Evora, Portugal
Kaunas Univeristy Hospital
🇱🇹Kaunas, Lithuania
Clinique Agdal
🇲🇦Rabat, Morocco
P. Stradins University Hospital
🇱🇻Riga, Latvia
Universitätsspital Zürich
🇨🇭Zürich, Switzerland
Teaching Hospital Brno
🇨🇿Brno, Czechia
Szpital im. Karola Marcinkowskiego
🇵🇱Poznan, Poland
Centre Hospitalier Privé Beauregard
🇫🇷Marseille, France
Masaryk Hospital Usti nad Labem
🇨🇿Usti nad Labem, Czechia
Hopital de la Cavale Blanche
🇫🇷Brest, France
Hôpital de la Tour
🇨🇭Meyrin, Geneva, Switzerland
Hospital Vall d'Hebrón
🇪🇸Barcelona, Spain
Universität Innsbruck
🇦🇹Innsbruck, Austria
KFJ - Hospital Vienna
🇦🇹Vienna, Austria
CHU Côte de Nacre
🇫🇷Caen, France
Clinique Saint-Hilaire
🇫🇷Rouen, France
Freeman Hospital
🇬🇧Newcastle, United Kingdom
Hospital San Juan de Alicante
🇪🇸Alicante, Spain
Salamanca Hospital
🇪🇸Salamanca, Spain
Hospital Clínico Universitario Santiago
🇪🇸Santiago, Spain
Centre Hospitalier Henri Mondor
🇫🇷Creteil, France
Polyclinique de Bois Bernard
🇫🇷Lille, France
CMC Parly II
🇫🇷Chesnay, France
Nouvelles Cliniques Nantaises
🇫🇷Nantes, France
AKH der Stadt Wien
🇦🇹Vienna, Austria
Mater Misericordiae
🇮🇪Dublin, Ireland
Institut Hospitalier Jacques Cartier
🇫🇷Massy, France
Vivantes Klinikum im Friedrichshain
🇩🇪Berlin, Germany
Clinique Générale
🇫🇷Marignane, France
Hôpital Militaire d'instruction Mohamed-V
🇲🇦Rabat, Morocco
Hôpital Cardiovasculaire et Pneumologique Louis Pradel
🇫🇷Bron, France
Golden Jubilee National Hospital
🇬🇧Glasgow, United Kingdom
Royal Infirmary of Edinburgh
🇬🇧Edinburgh, United Kingdom
Hospital Santa Maria del Rosell
🇪🇸Cartagena, Spain
Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
St Petersburg
🇷🇺St Petersburg, Russian Federation
Hospital de Galdácano
🇪🇸Galdakao, Spain
Brighton and Sussex University Hospitals
🇬🇧Brighton, United Kingdom
Frenchay Hospital
🇬🇧Bristol, United Kingdom
Hospital Dr Pesset
🇪🇸Valencia, Spain
Triemli Stadtspital
🇨🇭Zürich, Switzerland
Hospital Universitario Virgen de la Arrixaca
🇪🇸Murcia, Spain
Royal United Hospital Bath
🇬🇧Bath, United Kingdom
Papworth hospital
🇬🇧Cambridge, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
🇬🇧Sheffield, United Kingdom
Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
Dorset Country Hospital
🇬🇧Dorchester, United Kingdom
Royal Wolverhampton Hospitals
🇬🇧Wolverhampton, United Kingdom
Lister Hospital, London
🇬🇧London, United Kingdom
Plymouth Hospitals NHS Trust
🇬🇧Plymouth, United Kingdom
Queen Alexandra, Portsmouth
🇬🇧Portsmouth, United Kingdom
Roskilde Sygehus
🇩🇰Roskilde, Denmark
Belfast Health and Social Care TRUST,
🇬🇧Belfast, United Kingdom
Blackpool Victoria Hospital
🇬🇧Blackpool, United Kingdom
Polyclinique Les Fleurs
🇫🇷Ollioules, France
Hôpital de Rangueil - CHU
🇫🇷Toulouse, France
Moscow City Hospital
🇷🇺Moscow, Russian Federation
Hospital General de Valencia
🇪🇸Valencia, Spain
King's College
🇬🇧London, United Kingdom
Krankenanstalt Rudolfstiftung
🇦🇹Vienna, Austria
Clinique Rhône Durance
🇫🇷Avignon, France
St. James's Hospital
🇮🇪Dublin, Ireland
Szpital im. J. Strusia
🇵🇱Poznan, Poland
Kantonsspital St.Gallen
🇨🇭St. Gallen, Switzerland
Hairmyres Hospital
🇬🇧Glasgow, United Kingdom
Leeds General Infirmary
🇬🇧Leeds, United Kingdom
The Jordan Cardiovascular Center
🇯🇴Amman, Jordan
Hôpital Cantonal de Fribourg
🇨🇭Fribourg, Switzerland