e-BioMatrix PostMarket Registry
eBMX-PMR
A Postmarket Registry of the BioMatrix™ and BioMatrix Flex™ Drug Eluting Stents.
1 other identifier
observational
5,652
16 countries
69
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2008
Longer than P75 for all trials
69 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 2, 2011
CompletedFirst Posted
Study publicly available on registry
February 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedMay 6, 2019
May 1, 2019
4.4 years
February 2, 2011
May 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
stent thrombosis
30 days, 6 and 12 months, 2, 3 and 5 years
MACE
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
- +1 more secondary outcomes
Eligibility Criteria
"Real world, all comer" patients
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (69)
Universität Innsbruck
Innsbruck, Austria
AKH der Stadt Wien
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip Urban, MD
Hôpital de la Tour
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2011
First Posted
February 3, 2011
Study Start
April 1, 2008
Primary Completion
September 1, 2012
Study Completion
September 1, 2014
Last Updated
May 6, 2019
Record last verified: 2019-05