Coronary Artery StenosesNCT03461484
e-BioMatrix 6 Month DAPT France
An observational study of Coronary Artery Stenoses and Stable Angina, run by Biosensors Europe SA.
Trial summary
Prospective, multi-center observational study to be conducted in up to 30 French interventional cardiology centers. The purpose of this observational study is to capture, in French Centers, clinical data of the BioMatrix Flex™ and BioMatrix NeoFlex™ Drug Eluting Coronary Stents System (Biolimus A9, BA9™-) in normal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Stenoses, Stable Angina, Ischemia
- How many people
- 2,098 participants
- Where
- No sites listed yet
- Study dates
- 6 Mar 2014to 31 Oct 2019
- How long will I take part?
- 2 Years
- 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 comers" patient population: Patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions and can be treated with 6-month DAPT
Who may be able to join
- "Real world, all comer" patients
- Age ≥18 years;
- Patients that need a treatment with a BioMatrix Flex™ drug- eluting stent or a BioMatrix NeoFlex™drug-eluting stent;
- Presence of one or more coronary artery stenoses in a native coronary artery 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, vessels, and lesion length, within the limits of social security reimbursements;
- Patient with DAPT indication after PCI.
Who cannot join
- Inability to provide informed consent;
- Patients needing additional stent NOT of the BioMatrix Flex™ or NeoFlex™ types;
- Patients receiving next to the BioMatrix Flex™ or BioMatrix NeoFlex™ also other coronary vascular interventions, for example, balloon dilation;
- Pregnant or planning to become pregnant patient;
- DES and BMS implantation less than 6 months before screening;
About this study
Official title: A French Post-market Observational/Non-interventional Study of the BioMatrix Flex™ and BioMatrix Neo Flex™ Drug Eluting Stents With 6-month DAPT
Prospective, multi-center observational study to be conducted in up to 30 French interventional cardiology centers. The purpose of this observational study is to capture, in French Centers, clinical data of the BioMatrix Flex™ and BioMatrix NeoFlex™ Drug Eluting Coronary Stents System (Biolimus A9, BA9™-) in normal practice, in patients treated with 6-month DAPT, and to compare the outcomes to those of previous e-biomatrix registries with longer DAPT durations. The patients will be followed up for 2 years for data collection.
- Conditions
- Coronary Artery Stenoses, Stable Angina, Ischemia, NSTEMI - Non-ST Segment Elevation MI, STEMI
- Medical subject headings
- Coronary Stenosis, Angina, Stable, Ischemia, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac and cerebrovascular events (MACCE) in the overall population, defined as composite of all-cause death, cerebrovascular accidents, non fatal myocardial infarction or clinically-driven target vessel revascularization at 6 months
Major adverse cardiac and cerebrovascular events (MACCE) in the overall population, defined as composite of all-cause death, cerebrovascular accidents, non fatal myocardial infarction or clinically-driven target vessel revascularization at 6 months
Measured: 6 months
Secondary outcomes (7)
Primary and secondary stent thrombosis
Primary and secondary stent thrombosis (definite and probable according to ARC definitions) at 6 months and 2 years;
Measured: 6 months and 2 years
Major bleeding
Major bleeding (BARC 3, 4 and 5 definitions) at 6 months and 2 years
Measured: 6 months and 2 years
Major adverse cardiac and cerebrovascular events (MACCEs) in the overall population
Major adverse cardiac and cerebrovascular events (MACCEs) in the overall population, defined as composite of all cause death, myocardial infarction (Q-wave and non-Q-wave), cerebrovascular accidents or clinically-driven target vessel revascularization at 2 years
Measured: 2 years
Cardiac deaths at 6 months and and 2 years
Cardiac deaths at 6 months and and 2 years
Measured: 6 months and and 2 years
Patient Oriented Composite Endpoint defined as any cause mortality, MI (Q-wave and non-Q-wave), or any revascularization at 6 months and 2 years
Patient Oriented Composite Endpoint defined as any cause mortality, MI (Q-wave and non-Q-wave), or any revascularization at 6 months and 2 years
Measured: 6 months and 2 years
Death,MI and cerebrovascular accidents at 6 months and 2 years
Death,MI and cerebrovascular accidents at 6 months and 2 years
Measured: 6 months and 2 years
Death, post-procedural MI and cerebrovascular accidents at 6 months and 2 years
Death, post-procedural MI and cerebrovascular accidents at 6 months and 2 years
Measured: 6 months and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start6 Mar 2014
- Primary completion9 Apr 2018
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery StenosesStudies 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
- 2,098 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Biosensors Europe SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Responsible party
- Sponsor
- Investigators
- Christian Spaulding, MD, Principal investigator, Hôpital Européen Georges-PompidouLanusz Lipiecki, MD, Principal investigator, Clinique des Dômes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461484
- Sponsor's protocol ID
- 13-EU-02
- Status last verified
- May 2019
- First submitted
- 5 Mar 2018
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not planned
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A French Post-market Observational/Non-interventional Study of the BioMatrix Flex™ and BioMatrix Neo Flex™ Drug Eluting Stents With 6-month DAPT
- ClinicalTrials.gov ID
- NCT03461484
- Acronym / sponsor ID
- 13-EU-02
- Conditions
- Coronary Artery Stenoses, Stable Angina, Ischemia, NSTEMI - Non-ST Segment Elevation MI, STEMI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,098 participants (actual)
- Lead sponsor
- Biosensors Europe SAIndustry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Study start
- 6 Mar 2014 (actual)
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 12 Mar 2018 (actual)
- 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.
Prospective, multi-center observational study to be conducted in up to 30 French interventional cardiology centers. The purpose of this observational study is to capture, in French Centers, clinical data of the BioMatrix Flex™ and BioMatrix NeoFlex™ Drug Eluting Coronary Stents System (Biolimus A9, BA9™-) in normal practice, in patients treated with 6-month DAPT, and to compare the outcomes to those of previous e-biomatrix registries with longer DAPT durations. The patients will be followed up for 2 years for data collection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- "Real world, all comers" patient population: Patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions and can be treated with 6-month DAPT
Key inclusion criteria (6 listed)
- "Real world, all comer" patients
Key exclusion criteria (5 listed)
- Inability to provide informed consent;
- Patients needing additional stent NOT of the BioMatrix Flex™ or NeoFlex™ types;
- Patients receiving next to the BioMatrix Flex™ or BioMatrix NeoFlex™ also other coronary vascular interventions, for example, balloon dilation;
- Pregnant or planning to become pregnant patient;
- DES and BMS implantation less than 6 months before screening;
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 and cerebrovascular events (MACCE) in the overall population, defined as composite of all-cause death, cerebrovascular accidents, non fatal myocardial infarction or clinically-driven target vessel revascularization at 6 months
Time frame: 6 months
Major adverse cardiac and cerebrovascular events (MACCE) in the overall population, defined as composite of all-cause death, cerebrovascular accidents, non fatal myocardial infarction or clinically-driven target vessel revascularization at 6 months
7 secondary outcomes
Primary and secondary stent thrombosis
Time frame: 6 months and 2 years
Major bleeding
Time frame: 6 months and 2 years
Major adverse cardiac and cerebrovascular events (MACCEs) in the overall population
Time frame: 2 years
Cardiac deaths at 6 months and and 2 years
Time frame: 6 months and and 2 years
Patient Oriented Composite Endpoint defined as any cause mortality, MI (Q-wave and non-Q-wave), or any revascularization at 6 months and 2 years
Time frame: 6 months and 2 years
Death,MI and cerebrovascular accidents at 6 months and 2 years
Time frame: 6 months and 2 years
Death, post-procedural MI and cerebrovascular accidents at 6 months and 2 years
Time frame: 6 months and 2 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 15 Apr 2020.
- Individual participant dataSharing planned: No. Not planned
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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.
Christian Spaulding, MD principal investigator
Hôpital Européen Georges-Pompidou
Lanusz Lipiecki, MD principal investigator
Clinique des Dômes
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Stenoses and Stable Angina, run by Biosensors Europe SA.
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 6 inclusion and 5 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 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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 and cerebrovascular events (MACCE) in the overall population, defined as composite of all-cause death, cerebrovascular accidents, non fatal myocardial infarction or clinically-driven target vessel revascularization at 6 months (time frame: 6 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 15 Apr 2020; AzTrials last refreshed its copy on 26 Oct 2026.