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eBMX-PMR: e-BioMatrix PostMarket Registry

Sponsor
Biosensors Europe SA (Industry)
Overall Status
Completed
CT.gov ID
NCT01289002
Collaborator
(none)
5,652
Enrollment
69
Locations
77
Duration (Months)
81.9
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    5652 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Postmarket Registry of the BioMatrix™ and BioMatrix Flex™ Drug Eluting Stents.
    Study Start Date :
    Apr 1, 2008
    Actual Primary Completion Date :
    Sep 1, 2012
    Actual Study Completion Date :
    Sep 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. MACE [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

    1. stent thrombosis [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;

    2. MACE [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;

    3. 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]

    4. 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;]

    5. 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]

    6. Total revascularization rate (clinically and non clinically driven) at 30 days, 6 and 12 months, 2, 3 and 5 years. [30 days, 6 and 12 months, 2, 3 and 5 years.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Universität Innsbruck Innsbruck Austria
    2 AKH der Stadt Wien Vienna Austria
    3 KFJ - Hospital Vienna Vienna Austria
    4 Krankenanstalt Rudolfstiftung Vienna Austria
    5 Teaching Hospital Brno Brno Czechia
    6 Masaryk Hospital Usti nad Labem Usti nad Labem Czechia
    7 Roskilde Sygehus Roskilde Denmark
    8 Clinique Rhône Durance Avignon France
    9 Hopital de la Cavale Blanche Brest France
    10 Hôpital Cardiovasculaire et Pneumologique Louis Pradel Bron France
    11 CHU Côte de Nacre Caen France
    12 CMC Parly II Chesnay France
    13 Centre Hospitalier Henri Mondor Creteil France
    14 Polyclinique de Bois Bernard Lille France
    15 Clinique Générale Marignane France
    16 Centre Hospitalier Privé Beauregard Marseille France
    17 Institut Hospitalier Jacques Cartier Massy France
    18 Nouvelles Cliniques Nantaises Nantes France
    19 Polyclinique Les Fleurs Ollioules France
    20 Clinique Saint-Hilaire Rouen France
    21 Hôpital de Rangueil - CHU Toulouse France
    22 Vivantes Klinikum im Friedrichshain Berlin Germany
    23 Mater Misericordiae Dublin Ireland
    24 St. James's Hospital Dublin Ireland
    25 The Jordan Cardiovascular Center Amman Jordan
    26 P. Stradins University Hospital Riga Latvia
    27 Kaunas Univeristy Hospital Kaunas Lithuania
    28 Clinique Agdal Rabat Morocco
    29 Hôpital Militaire d'instruction Mohamed-V Rabat Morocco
    30 Szpital im. J. Strusia Poznan Poland
    31 Szpital im. Karola Marcinkowskiego Poznan Poland
    32 Hospital do Espirito Santo Evora Portugal
    33 Moscow City Hospital Moscow Russian Federation
    34 St Petersburg St Petersburg Russian Federation
    35 Hospital San Juan de Alicante Alicante Spain
    36 Hospital Vall d'Hebrón Barcelona Spain
    37 Hospital Santa Maria del Rosell Cartagena Spain
    38 Hospital de Galdácano Galdakao Spain
    39 Hospital Universitario Virgen de la Arrixaca Murcia Spain
    40 Salamanca Hospital Salamanca Spain
    41 Hospital Clínico Universitario Santiago Santiago Spain
    42 Hospital Dr Pesset Valencia Spain
    43 Hospital General de Valencia Valencia Spain
    44 Hôpital de la Tour Meyrin Geneva Switzerland 1217
    45 Hôpital Cantonal de Fribourg Fribourg Switzerland
    46 Kantonsspital St.Gallen St. Gallen Switzerland
    47 Triemli Stadtspital Zürich Switzerland
    48 Universitätsspital Zürich Zürich Switzerland
    49 Royal United Hospital Bath Bath United Kingdom
    50 Belfast Health and Social Care TRUST, Belfast United Kingdom
    51 Blackpool Victoria Hospital Blackpool United Kingdom
    52 Royal Bournemouth Hospital Bournemouth United Kingdom
    53 Brighton and Sussex University Hospitals Brighton United Kingdom
    54 Frenchay Hospital Bristol United Kingdom
    55 Papworth hospital Cambridge United Kingdom
    56 Craigavon Cardiac Center Craigavon United Kingdom
    57 Dorset Country Hospital Dorchester United Kingdom
    58 Royal Infirmary of Edinburgh Edinburgh United Kingdom
    59 Golden Jubilee National Hospital Glasgow United Kingdom
    60 Hairmyres Hospital Glasgow United Kingdom
    61 Leeds General Infirmary Leeds United Kingdom
    62 King's College London United Kingdom
    63 Lister Hospital, London London United Kingdom
    64 Manchester Royal Infirmary Manchester United Kingdom
    65 Freeman Hospital Newcastle United Kingdom
    66 Plymouth Hospitals NHS Trust Plymouth United Kingdom
    67 Queen Alexandra, Portsmouth Portsmouth United Kingdom
    68 Sheffield Teaching Hospitals NHS Foundation Trust Sheffield United Kingdom
    69 Royal Wolverhampton Hospitals Wolverhampton United Kingdom

    Sponsors and Collaborators

    • Biosensors Europe SA

    Investigators

    • Principal Investigator: Philip Urban, MD, Hôpital de la Tour

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biosensors Europe SA
    ClinicalTrials.gov Identifier:
    NCT01289002
    Other Study ID Numbers:
    • 07EU02
    First Posted:
    Feb 3, 2011
    Last Update Posted:
    May 6, 2019
    Last Verified:
    May 1, 2019
    Additional relevant MeSH terms:
    Coronary Artery Disease

    Study Results

    No Results Posted as of May 6, 2019