e-BioMatrix PostMarket Registry

NCT ID: NCT01289002

Last Updated: 2019-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5652 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2014-09-30

Brief Summary

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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

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Prospective, multi-center registry to be conducted at 60-70 international interventional cardiology centers. All patients will be followed for up to 3 years.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biosensors Europe SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip Urban, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital de la Tour

Locations

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Universität Innsbruck

Innsbruck, , Austria

Site Status

AKH der Stadt Wien

Vienna, , Austria

Site Status

KFJ - Hospital Vienna

Vienna, , Austria

Site Status

Krankenanstalt Rudolfstiftung

Vienna, , Austria

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Teaching Hospital Brno

Brno, , Czechia

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Masaryk Hospital Usti nad Labem

Ústí nad Labem, , Czechia

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Roskilde Sygehus

Roskilde, , Denmark

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Clinique Rhône Durance

Avignon, , France

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Hopital de la Cavale Blanche

Brest, , France

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Hôpital Cardiovasculaire et Pneumologique Louis Pradel

Bron, , France

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CHU Côte de Nacre

Caen, , France

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CMC Parly II

Chesnay, , France

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Centre Hospitalier Henri Mondor

Créteil, , France

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Polyclinique de Bois Bernard

Lille, , France

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Clinique Générale

Marignane, , France

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Centre Hospitalier Privé Beauregard

Marseille, , France

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Institut Hospitalier Jacques Cartier

Massy, , France

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Nouvelles Cliniques Nantaises

Nantes, , France

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Polyclinique Les Fleurs

Ollioules, , France

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Clinique Saint-Hilaire

Rouen, , France

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Hôpital de Rangueil - CHU

Toulouse, , France

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Vivantes Klinikum im Friedrichshain

Berlin, , Germany

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Mater Misericordiae

Dublin, , Ireland

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St. James's Hospital

Dublin, , Ireland

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The Jordan Cardiovascular Center

Amman, , Jordan

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P. Stradins University Hospital

Riga, , Latvia

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Kaunas Univeristy Hospital

Kaunas, , Lithuania

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Clinique Agdal

Rabat, , Morocco

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Hôpital Militaire d'instruction Mohamed-V

Rabat, , Morocco

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Szpital im. J. Strusia

Poznan, , Poland

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Szpital im. Karola Marcinkowskiego

Poznan, , Poland

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Hospital do Espirito Santo

Evora, , Portugal

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Moscow City Hospital

Moscow, , Russia

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St Petersburg

Saint Petersburg, , Russia

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Hospital San Juan de Alicante

Alicante, , Spain

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Hospital Vall d'Hebrón

Barcelona, , Spain

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Hospital Santa Maria del Rosell

Cartagena, , Spain

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Hospital de Galdácano

Galdakao, , Spain

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Hospital Universitario Virgen de la Arrixaca

Murcia, , Spain

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Salamanca Hospital

Salamanca, , Spain

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Hospital Clínico Universitario Santiago

Santiago, , Spain

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Hospital Dr Pesset

Valencia, , Spain

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Hospital General de Valencia

Valencia, , Spain

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Hôpital de la Tour

Meyrin, Canton of Geneva, Switzerland

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Hôpital Cantonal de Fribourg

Fribourg, , Switzerland

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Kantonsspital St.Gallen

Sankt Gallen, , Switzerland

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Triemli Stadtspital

Zurich, , Switzerland

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Universitätsspital Zürich

Zurich, , Switzerland

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Royal United Hospital Bath

Bath, , United Kingdom

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Belfast Health and Social Care TRUST,

Belfast, , United Kingdom

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Blackpool Victoria Hospital

Blackpool, , United Kingdom

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Royal Bournemouth Hospital

Bournemouth, , United Kingdom

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Brighton and Sussex University Hospitals

Brighton, , United Kingdom

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Frenchay Hospital

Bristol, , United Kingdom

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Papworth hospital

Cambridge, , United Kingdom

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Craigavon Cardiac Center

Craigavon, , United Kingdom

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Dorset Country Hospital

Dorchester, , United Kingdom

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Royal Infirmary of Edinburgh

Edinburgh, , United Kingdom

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Golden Jubilee National Hospital

Glasgow, , United Kingdom

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Hairmyres Hospital

Glasgow, , United Kingdom

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Leeds General Infirmary

Leeds, , United Kingdom

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King's College

London, , United Kingdom

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Lister Hospital, London

London, , United Kingdom

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Manchester Royal Infirmary

Manchester, , United Kingdom

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Freeman Hospital

Newcastle, , United Kingdom

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Plymouth Hospitals NHS Trust

Plymouth, , United Kingdom

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Queen Alexandra, Portsmouth

Portsmouth, , United Kingdom

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Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, , United Kingdom

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Royal Wolverhampton Hospitals

Wolverhampton, , United Kingdom

Site Status

Countries

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Austria Czechia Denmark France Germany Ireland Jordan Latvia Lithuania Morocco Poland Portugal Russia Spain Switzerland United Kingdom

Other Identifiers

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07EU02

Identifier Type: -

Identifier Source: org_study_id

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