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e-BioMatrix PostMarket Registry (eBMX-PMR)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by Biosensors Europe SA.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Biosensors Europe SA Identifier:
First received: February 2, 2011
Last updated: September 6, 2014
Last verified: September 2014
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.

Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Postmarket Registry of the BioMatrix™ and BioMatrix Flex™ Drug Eluting Stents.

Further study details as provided by Biosensors Europe SA:

Primary Outcome Measures:
  • MACE [ Time Frame: 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:
  • stent thrombosis [ Time Frame: 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;

  • MACE [ Time Frame: 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;

  • 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; [ Time Frame: 6 and 12 months, 2, 3 and 5 years ]
  • Death and MI at 30 days, 6 and 12 months, 2, 3 and 5 years; [ Time Frame: 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; [ Time Frame: 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. [ Time Frame: 30 days, 6 and 12 months, 2, 3 and 5 years. ]

Estimated Enrollment: 4000
Study Start Date: April 2008
Estimated Study Completion Date: April 2015
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
"Real world, all comer" patients

Inclusion Criteria:

  1. Age ≥18 years
  2. Patients that need a treatment with either a BioMatrix™ or a BioMatrix Flex™ drug-eluting stent
  3. 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
  4. No limitation on the number of treated lesions, and vessels, and lesion length

Exclusion Criteria:

  1. Inability to provide informed consent
  2. Patients needing additional stent NOT of the Biolimus A9™-eluting stent type
  3. Patients receiving next to the Biolimus A9™-eluting stent also other coronary vascular interventions, for example dilation
  4. Patients receiving both the BioMatrix™ and the BioMatrix Flex™ stent during index and/or staged procedure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01289002

  Hide Study Locations
Universität Innsbruck
Innsbruck, Austria
AKH der Stadt Wien
Vienna, Austria
KFJ - Hospital Vienna
Vienna, Austria
Krankenanstalt Rudolfstiftung
Vienna, Austria
Czech Republic
Teaching Hospital Brno
Brno, Czech Republic
Masaryk Hospital Usti nad Labem
Usti nad Labem, Czech Republic
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
Creteil, 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
Russian Federation
Moscow City Hospital
Moscow, Russian Federation
St Petersburg
St Petersburg, Russian Federation
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, Geneva, Switzerland, 1217
Hôpital Cantonal de Fribourg
Fribourg, Switzerland
Kantonsspital St.Gallen
St. Gallen, Switzerland
Triemli Stadtspital
Zürich, Switzerland
Universitätsspital Zürich
Zürich, Switzerland
United Kingdom
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
Sponsors and Collaborators
Biosensors Europe SA
Principal Investigator: Philip Urban, MD Hôpital de la Tour
  More Information

Responsible Party: Biosensors Europe SA Identifier: NCT01289002     History of Changes
Other Study ID Numbers: 07EU02
Study First Received: February 2, 2011
Last Updated: September 6, 2014

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on May 23, 2017