Clinical trial NCT01289002: e-BioMatrix PostMarket Registry
Official title: A Postmarket Registry of the BioMatrix™ and BioMatrix Flex™ Drug Eluting Stents.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Biosensors Europe SA
Sponsor class: INDUSTRY
First posted: 2011-02-03
Enrollment: 5652
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: "Real world, all comer" patients

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.

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.

Eligibility 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

Primary outcomes:
measure: MACE
timeFrame: 12 months
Secondary outcomes:
measure: stent thrombosis
timeFrame: 30 days, 6 and 12 months, 2, 3 and 5 years
measure: MACE
timeFrame: 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.
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Universität Innsbruck
city: Vienna
country: Austria
facility: AKH der Stadt Wien
city: Vienna
country: Austria
facility: KFJ - Hospital Vienna
city: Vienna
country: Austria
facility: Krankenanstalt Rudolfstiftung
city: Brno
country: Czechia
facility: Teaching Hospital Brno
city: Usti nad Labem
country: Czechia
facility: Masaryk Hospital Usti nad Labem
city: Roskilde
country: Denmark
facility: Roskilde Sygehus
city: Avignon
country: France
facility: Clinique Rhône Durance
city: Brest
country: France
facility: Hopital de la Cavale Blanche
city: Bron
country: France
facility: Hôpital Cardiovasculaire et Pneumologique Louis Pradel
city: Caen
country: France
facility: CHU Côte de Nacre
city: Chesnay
country: France
facility: CMC Parly II
city: Creteil
country: France
facility: Centre Hospitalier Henri Mondor
city: Lille
country: France
facility: Polyclinique de Bois Bernard
city: Marignane
country: France
facility: Clinique Générale
city: Marseille
country: France
facility: Centre Hospitalier Privé Beauregard
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Ollioules
country: France
facility: Polyclinique Les Fleurs
city: Rouen
country: France
facility: Clinique Saint-Hilaire
city: Toulouse
country: France
facility: Hôpital de Rangueil - CHU
city: Berlin
country: Germany
facility: Vivantes Klinikum im Friedrichshain
city: Dublin
country: Ireland
facility: Mater Misericordiae
city: Dublin
country: Ireland
facility: St. James's Hospital
city: Amman
country: Jordan
facility: The Jordan Cardiovascular Center
city: Riga
country: Latvia
facility: P. Stradins University Hospital
city: Kaunas
country: Lithuania
facility: Kaunas Univeristy Hospital
city: Rabat
country: Morocco
facility: Clinique Agdal
city: Rabat
country: Morocco
facility: Hôpital Militaire d'instruction Mohamed-V
city: Poznan
country: Poland
facility: Szpital im. J. Strusia
city: Poznan
country: Poland
facility: Szpital im. Karola Marcinkowskiego
city: Evora
country: Portugal
facility: Hospital do Espirito Santo
city: Moscow
country: Russian Federation
facility: Moscow City Hospital
city: St Petersburg
country: Russian Federation
facility: St Petersburg
city: Alicante
country: Spain
facility: Hospital San Juan de Alicante
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebrón
city: Cartagena
country: Spain
facility: Hospital Santa Maria del Rosell
city: Galdakao
country: Spain
facility: Hospital de Galdácano
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
city: Salamanca
country: Spain
facility: Salamanca Hospital
city: Santiago
country: Spain
facility: Hospital Clínico Universitario Santiago
city: Valencia
country: Spain
facility: Hospital Dr Pesset
city: Valencia
country: Spain
facility: Hospital General de Valencia
city: Meyrin
country: Switzerland
facility: Hôpital de la Tour
state: Geneva
city: Fribourg
country: Switzerland
facility: Hôpital Cantonal de Fribourg
city: St. Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
city: Zürich
country: Switzerland
facility: Triemli Stadtspital
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
city: Bath
country: United Kingdom
facility: Royal United Hospital Bath
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care TRUST,
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Brighton
country: United Kingdom
facility: Brighton and Sussex University Hospitals
city: Bristol
country: United Kingdom
facility: Frenchay Hospital
city: Cambridge
country: United Kingdom
facility: Papworth hospital
city: Craigavon
country: United Kingdom
facility: Craigavon Cardiac Center
city: Dorchester
country: United Kingdom
facility: Dorset Country Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Glasgow
country: United Kingdom
facility: Hairmyres Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: London
country: United Kingdom
facility: King's College
city: London
country: United Kingdom
facility: Lister Hospital, London
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra, Portsmouth
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
city: Wolverhampton
country: United Kingdom
facility: Royal Wolverhampton Hospitals
Study officials:
affiliation: Hôpital de la Tour
name: Philip Urban, MD
role: PRINCIPAL_INVESTIGATOR
References: