Coronary Artery DiseaseeBMX-PMRNCT01289002
e-BioMatrix PostMarket Registry
An observational study of Coronary Artery Disease, run by Biosensors Europe SA at 69 sites in 16 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 5,652 participants
- Where
- 69 sitesin 16 countries
- Study dates
- Apr 2008to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: "Real world, all comer" patients
Who may be able to join
- Age ≥18 years
- Patients that need a treatment with either a BioMatrix™ or a BioMatrix Flex™ drug-eluting stent
- 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
- No limitation on the number of treated lesions, and vessels, and lesion length
Who cannot join
- Inability to provide informed consent
- Patients needing additional stent NOT of the Biolimus A9™-eluting stent type
- Patients receiving next to the Biolimus A9™-eluting stent also other coronary vascular interventions, for example dilation
- Patients receiving both the BioMatrix™ and the BioMatrix Flex™ stent during index and/or staged procedure
Trial locations and contacts
69 sites in 16 countries.
69 sites in 16 countries
United Kingdom21 sites
Royal United Hospital Bath
Bath
Belfast Health and Social Care TRUST,
Belfast
Blackpool Victoria Hospital
Blackpool
Royal Bournemouth Hospital
Bournemouth
Brighton and Sussex University Hospitals
Brighton
Frenchay Hospital
Bristol
Papworth hospital
Cambridge
Craigavon Cardiac Center
Craigavon
Dorset Country Hospital
Dorchester
Royal Infirmary of Edinburgh
Edinburgh
Golden Jubilee National Hospital
Glasgow
Hairmyres Hospital
Glasgow
Leeds General Infirmary
Leeds
King's College
London
Lister Hospital, London
London
Manchester Royal Infirmary
Manchester
Freeman Hospital
Newcastle
Plymouth Hospitals NHS Trust
Plymouth
Queen Alexandra, Portsmouth
Portsmouth
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
Royal Wolverhampton Hospitals
Wolverhampton
France14 sites
Clinique Rhône Durance
Avignon
Hopital de la Cavale Blanche
Brest
Hôpital Cardiovasculaire et Pneumologique Louis Pradel
Bron
CHU Côte de Nacre
Caen
CMC Parly II
Chesnay
Centre Hospitalier Henri Mondor
Créteil
Polyclinique de Bois Bernard
Lille
Clinique Générale
Marignane
Centre Hospitalier Privé Beauregard
Marseille
Institut Hospitalier Jacques Cartier
Massy
Nouvelles Cliniques Nantaises
Nantes
Polyclinique Les Fleurs
Ollioules
Clinique Saint-Hilaire
Rouen
Hôpital de Rangueil - CHU
Toulouse
Spain9 sites
Hospital San Juan de Alicante
Alicante
Hospital Vall d'Hebrón
Barcelona
Hospital Santa Maria del Rosell
Cartagena
Hospital de Galdácano
Galdakao
Hospital Universitario Virgen de la Arrixaca
Murcia
Salamanca Hospital
Salamanca
Hospital Clínico Universitario Santiago
Santiago
Hospital Dr Pesset
Valencia
Hospital General de Valencia
Valencia
Switzerland5 sites
Hôpital Cantonal de Fribourg
Fribourg
Hôpital de la Tour
Meyrin, Canton of Geneva, 1217
Kantonsspital St.Gallen
Sankt Gallen
Triemli Stadtspital
Zurich
Universitätsspital Zürich
Zurich
Austria4 sites
Universität Innsbruck
Innsbruck
AKH der Stadt Wien
Vienna
KFJ - Hospital Vienna
Vienna
Krankenanstalt Rudolfstiftung
Vienna
Czechia2 sites
Teaching Hospital Brno
Brno
Masaryk Hospital Usti nad Labem
Ústí nad Labem
Morocco2 sites
Clinique Agdal
Rabat
Hôpital Militaire d'instruction Mohamed-V
Rabat
Poland2 sites
Szpital im. J. Strusia
Poznan
Szpital im. Karola Marcinkowskiego
Poznan
About this study
Official title: A Postmarket Registry of the BioMatrix™ and BioMatrix Flex™ Drug Eluting Stents.
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
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;
Measured: 30 days, 6 and 12 months, 2, 3 and 5 years
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;
Measured: 30 days, 6 months, 2, 3 and 5 years;
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;
Measured: 6 and 12 months, 2, 3 and 5 years
Death and MI at 30 days, 6 and 12 months, 2, 3 and 5 years;
Measured: 30 days, 6 and 12 months, 2, 3 and 5 years;
Death and post-procedural MI at 30 days, 6 and 12 months, 2, 3 and 5 years;
Measured: 30 days, 6 and 12 months, 2, 3 and 5 years
Total revascularization rate (clinically and non clinically driven) at 30 days, 6 and 12 months, 2, 3 and 5 years.
Measured: 30 days, 6 and 12 months, 2, 3 and 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startApr 2008
- Primary completionSep 2012
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,652 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosensors Europe SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Urban, MD, Principal investigator, Hôpital de la Tour
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289002
- Sponsor's protocol ID
- 07EU02
- Acronym
- eBMX-PMR
- Status last verified
- May 2019
- First submitted
- 2 Feb 2011
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Postmarket Registry of the BioMatrix™ and BioMatrix Flex™ Drug Eluting Stents.
- ClinicalTrials.gov ID
- NCT01289002
- Acronym / sponsor ID
- eBMX-PMR / 07EU02
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,652 participants (actual)
- Lead sponsor
- Biosensors Europe SAIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 3 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- "Real world, all comer" patients
Key inclusion criteria (4 listed)
- Age ≥18 years
- Patients that need a treatment with either a BioMatrix™ or a BioMatrix Flex™ drug-eluting stent
- 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
- No limitation on the number of treated lesions, and vessels, and lesion length
Key exclusion criteria (4 listed)
- Inability to provide informed consent
- Patients needing additional stent NOT of the Biolimus A9™-eluting stent type
- Patients receiving next to the Biolimus A9™-eluting stent also other coronary vascular interventions, for example dilation
- Patients receiving both the BioMatrix™ and the BioMatrix Flex™ stent during index and/or staged procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MACE
Time frame: 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.
6 secondary outcomes
stent thrombosis
Time frame: 30 days, 6 and 12 months, 2, 3 and 5 years
MACE
Time frame: 30 days, 6 months, 2, 3 and 5 years;
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;
Time frame: 6 and 12 months, 2, 3 and 5 years
Death and MI at 30 days, 6 and 12 months, 2, 3 and 5 years;
Time frame: 30 days, 6 and 12 months, 2, 3 and 5 years;
Death and post-procedural MI at 30 days, 6 and 12 months, 2, 3 and 5 years;
Time frame: 30 days, 6 and 12 months, 2, 3 and 5 years
Total revascularization rate (clinically and non clinically driven) at 30 days, 6 and 12 months, 2, 3 and 5 years.
Time frame: 30 days, 6 and 12 months, 2, 3 and 5 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Urban, MD principal investigator
Hôpital de la Tour
69 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Biosensors Europe SA at 69 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United Kingdom, France, Spain, Switzerland, Austria and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.