Coronary Artery DiseaseNCT01254487
e-BioMatrix PostMarket Surveillance Registry
An observational study of Coronary Artery Disease, run by Biosensors Europe SA at 9 sites in 3 countries.
Trial summary
The purpose of the e-BioMatrix PMS registry is to capture clinical data of the BioMatrix (Biolimus A9-Eluting) stent system 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
- 1,121 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Mar 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 a BioMatrix™ 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 BioMatrix™ type
- Patients receiving next to the BioMatrix™ stent also other coronary vascular interventions, for example dilation.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Switzerland6 sites
Inselspital
Bern, 3010
Hôpital Cantonal de Fribourg
Fribourg, 1708
Hôpitaux Universitaires de Genève
Geneva, 1211
Cardiocentro Ticino
Lugano, 6900
Hôpital de La Tour
Meyrin, 1217
Triemli Hospital
Zurich, 8063
United Kingdom2 sites
Brighton-Sussex University Hospitals
Brighton, BN2 5BE
Manchester Heart Center
Manchester, M13 9WL
About this study
Official title: A Postmarket Surveillance Registry of the BioMatrix Drug-eluting Stent
The purpose of the e-BioMatrix PMS registry is to capture clinical data of the BioMatrix (Biolimus A9-Eluting) stent system in relation to safety and effectiveness.
- 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.
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
Measured: 12 Months
Secondary outcomes (5)
Primary and secondary stent thrombosis (definite and probable according to ARC definitions)
Measured: 30 days, 6 and 12 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
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
Measured: 30 days, 6 and 12 months, 2, 3 and 5 years
Death and MI
Measured: 30 days, 6 and 12 months, 2, 3 and 5 years
Total revascularization rate (clinically and non clinically driven)
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 posted6 Dec 2010 (estimated)
- Study startMar 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
- 1,121 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
- NCT01254487
- Sponsor's protocol ID
- 07EU01
- Status last verified
- May 2019
- First submitted
- 3 Dec 2010
- 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 Surveillance Registry of the BioMatrix Drug-eluting Stent
- ClinicalTrials.gov ID
- NCT01254487
- Acronym / sponsor ID
- 07EU01
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,121 participants (actual)
- Lead sponsor
- Biosensors Europe SAIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 6 Dec 2010 (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 the e-BioMatrix PMS registry is to capture clinical data of the BioMatrix (Biolimus A9-Eluting) stent system in relation to safety and effectiveness.
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 a BioMatrix™ 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 (3 listed)
- Inability to provide informed consent
- Patients needing additional stent NOT of the BioMatrix™ type
- Patients receiving next to the BioMatrix™ stent also other coronary vascular interventions, for example dilation.
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
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
Time frame: 12 Months
5 secondary outcomes
Primary and secondary stent thrombosis (definite and probable according to ARC definitions)
Time frame: 30 days, 6 and 12 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
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
Time frame: 30 days, 6 and 12 months, 2, 3 and 5 years
Death and MI
Time frame: 30 days, 6 and 12 months, 2, 3 and 5 years
Total revascularization rate (clinically and non clinically driven)
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.
Related trials for Coronary Artery Disease
Recruiting
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention
Active, not recruitingObservational study
Post-Induction Low Cardiac Output Syndrome in Coronary Artery Bypass Graft Surgery
Cardiac Output, Low, Coronary Arterial Disease
RecruitingPhase 3
A Clinical Trial To Investigate The Effect Of EA-230 On Hospital Length Of Stay In Patients With Coronary Artery Disease (CAD) Undergoing Coronary Artery Bypass Grafting (CABG) Surgery.
Coronary Artery Disease (CAD), Coronary Artery Bypass Graft Surgery(CABG)
Enrolling by invitationObservational study
Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study
Non-obstructive Coronary Disease, Acute or Chronic Coronary Artery Disease
Recruiting
Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma
Melanoma
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
9 sites in 3 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 9 sites in 3 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 3 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 9 sites in Switzerland, United Kingdom, Spain. 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?
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 (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.