e-BioMatrix PostMarket Registry (eBMX-PMR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biosensors Europe SA
ClinicalTrials.gov Identifier:
NCT01289002
First received: February 2, 2011
Last updated: January 1, 2013
Last verified: January 2013
  Purpose

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.


Condition
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.

Resource links provided by NLM:


Further study details as provided by Biosensors Europe SA:

Primary Outcome Measures:
  • MACE [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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; ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • 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; ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 4000
Study Start Date: April 2008
Estimated Study Completion Date: September 2016
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 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

"Real world, all comer" patients

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289002

  Hide Study Locations
Locations
Austria
Universität Innsbruck
Innsbruck, Austria
KFJ - Hospital Vienna
Vienna, Austria
AKH der Stadt Wien
Vienna, Austria
Krankenanstalt Rudolfstiftung
Vienna, Austria
Czech Republic
Teaching Hospital Brno
Brno, Czech Republic
Masaryk Hospital Usti nad Labem
Usti nad Labem, Czech Republic
Denmark
Roskilde Sygehus
Roskilde, Denmark
France
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
Germany
Vivantes Klinikum im Friedrichshain
Berlin, Germany
Ireland
St. James's Hospital
Dublin, Ireland
Mater Misericordiae
Dublin, Ireland
Jordan
The Jordan Cardiovascular Center
Amman, Jordan
Latvia
P. Stradins University Hospital
Riga, Latvia
Lithuania
Kaunas Univeristy Hospital
Kaunas, Lithuania
Morocco
Clinique Agdal
Rabat, Morocco
Hôpital Militaire d'instruction Mohamed-V
Rabat, Morocco
Poland
Szpital im. Karola Marcinkowskiego
Poznan, Poland
Szpital im. J. Strusia
Poznan, Poland
Portugal
Hospital do Espirito Santo
Evora, Portugal
Russian Federation
Moscow City Hospital
Moscow, Russian Federation
St Petersburg
St Petersburg, Russian Federation
Spain
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
Switzerland
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
Investigators
Principal Investigator: Philip Urban, MD Hôpital de la Tour
  More Information

No publications provided

Responsible Party: Biosensors Europe SA
ClinicalTrials.gov Identifier: NCT01289002     History of Changes
Other Study ID Numbers: 07EU02
Study First Received: February 2, 2011
Last Updated: January 1, 2013
Health Authority: Switzerland: Ethikkommission
United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014