Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-02-28 @ 11:20 AM
Study NCT ID:
NCT01289002
Status:
COMPLETED
Last Update Posted:
2019-05-06
First Post:
2011-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
e-BioMatrix PostMarket Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5652}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-03', 'studyFirstSubmitDate': '2011-02-02', 'studyFirstSubmitQcDate': '2011-02-02', 'lastUpdatePostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACE', 'timeFrame': '12 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'stent thrombosis', 'timeFrame': '30 days, 6 and 12 months, 2, 3 and 5 years', 'description': 'Primary and secondary stent thrombosis (definite and probable according to ARC definitions) at 30 days, 6 and 12 months, 2, 3 and 5 years;'}, {'measure': 'MACE', 'timeFrame': '30 days, 6 months, 2, 3 and 5 years;', 'description': '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;'}, {'measure': '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;', 'timeFrame': '6 and 12 months, 2, 3 and 5 years'}, {'measure': 'Death and MI at 30 days, 6 and 12 months, 2, 3 and 5 years;', 'timeFrame': '30 days, 6 and 12 months, 2, 3 and 5 years;'}, {'measure': 'Death and post-procedural MI at 30 days, 6 and 12 months, 2, 3 and 5 years;', 'timeFrame': '30 days, 6 and 12 months, 2, 3 and 5 years'}, {'measure': 'Total revascularization rate (clinically and non clinically driven) at 30 days, 6 and 12 months, 2, 3 and 5 years.', 'timeFrame': '30 days, 6 and 12 months, 2, 3 and 5 years.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Prospective, multi-center registry to be conducted at 60-70 international interventional cardiology centers. All patients will be followed for up to 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '"Real world, all comer" patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years\n2. Patients that need a treatment with either a BioMatrix™ or a BioMatrix Flex™ drug-eluting stent\n3. 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\n4. No limitation on the number of treated lesions, and vessels, and lesion length\n\nExclusion Criteria:\n\n1. Inability to provide informed consent\n2. Patients needing additional stent NOT of the Biolimus A9™-eluting stent type\n3. Patients receiving next to the Biolimus A9™-eluting stent also other coronary vascular interventions, for example dilation\n4. Patients receiving both the BioMatrix™ and the BioMatrix Flex™ stent during index and/or staged procedure'}, 'identificationModule': {'nctId': 'NCT01289002', 'acronym': 'eBMX-PMR', 'briefTitle': 'e-BioMatrix PostMarket Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biosensors Europe SA'}, 'officialTitle': 'A Postmarket Registry of the BioMatrix™ and BioMatrix Flex™ Drug Eluting Stents.', 'orgStudyIdInfo': {'id': '07EU02'}}, 'contactsLocationsModule': {'locations': [{'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Universität Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'AKH der Stadt Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'KFJ - Hospital Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Krankenanstalt Rudolfstiftung', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Brno', 'country': 'Czechia', 'facility': 'Teaching Hospital Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Ústí nad Labem', 'country': 'Czechia', 'facility': 'Masaryk Hospital Usti nad Labem', 'geoPoint': {'lat': 50.6607, 'lon': 14.03227}}, {'city': 'Roskilde', 'country': 'Denmark', 'facility': 'Roskilde Sygehus', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}, {'city': 'Avignon', 'country': 'France', 'facility': 'Clinique Rhône Durance', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'city': 'Brest', 'country': 'France', 'facility': 'Hopital de la Cavale Blanche', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Bron', 'country': 'France', 'facility': 'Hôpital Cardiovasculaire et Pneumologique Louis Pradel', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'city': 'Caen', 'country': 'France', 'facility': 'CHU Côte de Nacre', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Chesnay', 'country': 'France', 'facility': 'CMC Parly II', 'geoPoint': {'lat': 48.283, 'lon': 1.76683}}, {'city': 'Créteil', 'country': 'France', 'facility': 'Centre Hospitalier Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Lille', 'country': 'France', 'facility': 'Polyclinique de Bois Bernard', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Marignane', 'country': 'France', 'facility': 'Clinique Générale', 'geoPoint': {'lat': 43.41727, 'lon': 5.21462}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Centre Hospitalier Privé Beauregard', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Massy', 'country': 'France', 'facility': 'Institut Hospitalier Jacques Cartier', 'geoPoint': {'lat': 48.72692, 'lon': 2.28301}}, {'city': 'Nantes', 'country': 'France', 'facility': 'Nouvelles Cliniques Nantaises', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Ollioules', 'country': 'France', 'facility': 'Polyclinique Les Fleurs', 'geoPoint': {'lat': 43.1399, 'lon': 5.84766}}, {'city': 'Rouen', 'country': 'France', 'facility': 'Clinique Saint-Hilaire', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Hôpital de Rangueil - CHU', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Vivantes Klinikum im Friedrichshain', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Mater Misericordiae', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': "St. James's Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Amman', 'country': 'Jordan', 'facility': 'The Jordan Cardiovascular Center', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}, {'city': 'Riga', 'country': 'Latvia', 'facility': 'P. Stradins University Hospital', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Kaunas Univeristy Hospital', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'city': 'Rabat', 'country': 'Morocco', 'facility': 'Clinique Agdal', 'geoPoint': {'lat': 34.01325, 'lon': -6.83255}}, {'city': 'Rabat', 'country': 'Morocco', 'facility': "Hôpital Militaire d'instruction Mohamed-V", 'geoPoint': {'lat': 34.01325, 'lon': -6.83255}}, {'city': 'Poznan', 'country': 'Poland', 'facility': 'Szpital im. J. Strusia', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Poznan', 'country': 'Poland', 'facility': 'Szpital im. Karola Marcinkowskiego', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Evora', 'country': 'Portugal', 'facility': 'Hospital do Espirito Santo', 'geoPoint': {'lat': 38.56587, 'lon': -7.90405}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Moscow City Hospital', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'St Petersburg', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Alicante', 'country': 'Spain', 'facility': 'Hospital San Juan de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Vall d'Hebrón", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Cartagena', 'country': 'Spain', 'facility': 'Hospital Santa Maria del Rosell', 'geoPoint': {'lat': 37.60197, 'lon': -0.98397}}, {'city': 'Galdakao', 'country': 'Spain', 'facility': 'Hospital de Galdácano', 'geoPoint': {'lat': 43.23073, 'lon': -2.8429}}, {'city': 'Murcia', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de la Arrixaca', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'city': 'Salamanca', 'country': 'Spain', 'facility': 'Salamanca Hospital', 'geoPoint': {'lat': 40.42972, 'lon': -3.67975}}, {'city': 'Santiago', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario Santiago', 'geoPoint': {'lat': 37.9358, 'lon': -4.13866}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Dr Pesset', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital General de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '1217', 'city': 'Meyrin', 'state': 'Canton of Geneva', 'country': 'Switzerland', 'facility': 'Hôpital de la Tour', 'geoPoint': {'lat': 46.23424, 'lon': 6.08025}}, {'city': 'Fribourg', 'country': 'Switzerland', 'facility': 'Hôpital Cantonal de Fribourg', 'geoPoint': {'lat': 46.80237, 'lon': 7.15128}}, {'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Kantonsspital St.Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Triemli Stadtspital', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Universitätsspital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'city': 'Bath', 'country': 'United Kingdom', 'facility': 'Royal United Hospital Bath', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}, {'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'Belfast Health and Social Care TRUST,', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'city': 'Blackpool', 'country': 'United Kingdom', 'facility': 'Blackpool Victoria Hospital', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'city': 'Bournemouth', 'country': 'United Kingdom', 'facility': 'Royal Bournemouth Hospital', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'city': 'Brighton', 'country': 'United Kingdom', 'facility': 'Brighton and Sussex University Hospitals', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Frenchay Hospital', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Papworth hospital', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'Craigavon', 'country': 'United Kingdom', 'facility': 'Craigavon Cardiac Center', 'geoPoint': {'lat': 54.44709, 'lon': -6.387}}, {'city': 'Dorchester', 'country': 'United Kingdom', 'facility': 'Dorset Country Hospital', 'geoPoint': {'lat': 50.71667, 'lon': -2.43333}}, {'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Royal Infirmary of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Golden Jubilee National Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Hairmyres Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Leeds General Infirmary', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "King's College", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Lister Hospital, London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester Royal Infirmary', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Newcastle', 'country': 'United Kingdom', 'facility': 'Freeman Hospital', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}, {'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Plymouth Hospitals NHS Trust', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'city': 'Portsmouth', 'country': 'United Kingdom', 'facility': 'Queen Alexandra, Portsmouth', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}, {'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Sheffield Teaching Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'city': 'Wolverhampton', 'country': 'United Kingdom', 'facility': 'Royal Wolverhampton Hospitals', 'geoPoint': {'lat': 52.58547, 'lon': -2.12296}}], 'overallOfficials': [{'name': 'Philip Urban, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital de la Tour'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biosensors Europe SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}