e-BioMatrix PostMarket Registry

Coronary Artery Disease Clinical Trial

— eBMX-PMR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289002
• Other study ID #: 07EU02
• Status: Completed
• Start date: April 2008
• Est. completion date: September 2014

Study information

• Verified date: May 2019
• Source: Biosensors Europe SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5652
• Est. completion date: September 2014
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Biosensors Europe SA

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE	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	stent thrombosis	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
Secondary	MACE	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;
Secondary	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
Secondary	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;
Secondary	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
Secondary	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.