e-BioMatrix PostMarket Registry (eBMX-PMR)

May 3, 2019 updated by: Biosensors Europe SA

A Postmarket Registry of the BioMatrix™ and BioMatrix Flex™ Drug Eluting Stents.

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

5652

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
        • Universität Innsbruck
      • Vienna, Austria
        • AKH der Stadt Wien
      • Vienna, Austria
        • KFJ - Hospital Vienna
      • Vienna, Austria
        • Krankenanstalt Rudolfstiftung
  • Czechia
      • Brno, Czechia
        • Teaching Hospital Brno
      • Usti nad Labem, Czechia
        • Masaryk Hospital Usti nad Labem
  • Denmark
      • Roskilde, Denmark
        • Roskilde Sygehus
  • France
      • Avignon, France
        • Clinique Rhône Durance
      • Brest, France
        • Hôpital de la Cavale blanche
      • Bron, France
        • Hopital Cardiovasculaire et Pneumologique Louis Pradel
      • Caen, France
        • CHU Côte de Nacre
      • Chesnay, France
        • CMC Parly II
      • Creteil, France
        • Centre Hospitalier Henri Mondor
      • Lille, France
        • Polyclinique de Bois Bernard
      • Marignane, France
        • Clinique Générale
      • Marseille, France
        • Centre Hospitalier Privé Beauregard
      • Massy, France
        • Institut Hospitalier Jacques Cartier
      • Nantes, France
        • Nouvelles Cliniques Nantaises
      • Ollioules, France
        • Polyclinique Les Fleurs
      • Rouen, France
        • Clinique Saint-Hilaire
      • Toulouse, France
        • Hôpital de Rangueil - CHU
  • Germany
      • Berlin, Germany
        • Vivantes Klinikum im Friedrichshain
  • Ireland
      • Dublin, Ireland
        • St. James's Hospital
      • Dublin, Ireland
        • Mater Misericordiae
  • Jordan
      • Amman, Jordan
        • The Jordan Cardiovascular Center
  • Latvia
      • Riga, Latvia
        • P. Stradins University Hospital
  • Lithuania
      • Kaunas, Lithuania
        • Kaunas Univeristy Hospital
  • Morocco
      • Rabat, Morocco
        • Clinique Agdal
      • Rabat, Morocco
        • Hôpital Militaire d'instruction Mohamed-V
  • Poland
      • Poznan, Poland
        • Szpital im. J. Strusia
      • Poznan, Poland
        • Szpital im. Karola Marcinkowskiego
  • Portugal
      • Evora, Portugal
        • Hospital do Espirito Santo
  • Russian Federation
      • Moscow, Russian Federation
        • Moscow City Hospital
      • St Petersburg, Russian Federation
        • St Petersburg
  • Spain
      • Alicante, Spain
        • Hospital San Juan de Alicante
      • Barcelona, Spain
        • Hospital Vall d'Hebron
      • Cartagena, Spain
        • Hospital Santa Maria del Rosell
      • Galdakao, Spain
        • Hospital de Galdácano
      • Murcia, Spain
        • Hospital Universitario Virgen de La Arrixaca
      • Salamanca, Spain
        • Salamanca Hospital
      • Santiago, Spain
        • Hospital Clínico Universitario Santiago
      • Valencia, Spain
        • Hospital General de Valencia
      • Valencia, Spain
        • Hospital Dr Pesset
  • Switzerland
      • Fribourg, Switzerland
        • Hôpital Cantonal de Fribourg
      • St. Gallen, Switzerland
        • Kantonsspital St.Gallen
      • Zürich, Switzerland
        • Universitatsspital Zurich
      • Zürich, Switzerland
        • Triemli Stadtspital
    • Geneva
      • Meyrin, Geneva, Switzerland, 1217
        • Hôpital de la Tour
  • United Kingdom
      • Bath, United Kingdom
        • Royal United Hospital Bath
      • Belfast, United Kingdom
        • Belfast Health and Social Care TRUST,
      • Blackpool, United Kingdom
        • Blackpool Victoria Hospital
      • Bournemouth, United Kingdom
        • Royal Bournemouth Hospital
      • Brighton, United Kingdom
        • Brighton and Sussex University Hospitals
      • Bristol, United Kingdom
        • Frenchay Hospital
      • Cambridge, United Kingdom
        • Papworth Hospital
      • Craigavon, United Kingdom
        • Craigavon Cardiac Center
      • Dorchester, United Kingdom
        • Dorset Country Hospital
      • Edinburgh, United Kingdom
        • Royal Infirmary of Edinburgh
      • Glasgow, United Kingdom
        • Golden Jubilee National Hospital
      • Glasgow, United Kingdom
        • Hairmyres Hospital
      • Leeds, United Kingdom
        • Leeds General Infirmary
      • London, United Kingdom
        • King's College
      • London, United Kingdom
        • Lister Hospital, London
      • Manchester, United Kingdom
        • Manchester Royal Infirmary
      • Newcastle, United Kingdom
        • Freeman Hospital
      • Plymouth, United Kingdom
        • Plymouth Hospitals NHS Trust
      • Portsmouth, United Kingdom
        • Queen Alexandra, Portsmouth
      • Sheffield, United Kingdom
        • Sheffield Teaching Hospitals NHS Foundation Trust
      • Wolverhampton, United Kingdom
        • Royal Wolverhampton Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

"Real world, all comer" patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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;
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;
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
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;
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
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.
30 days, 6 and 12 months, 2, 3 and 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosensors Europe SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

February 2, 2011

First Submitted That Met QC Criteria

February 2, 2011

First Posted (Estimate)

February 3, 2011

Study Record Updates

Last Update Posted (Actual)

May 6, 2019

Last Update Submitted That Met QC Criteria

May 3, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07EU02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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