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CompletedNCT03461484Updated Apr 15, 2020

e-BioMatrix 6 Month DAPT France

An observational study in Coronary Artery Stenoses, Stable Angina and Ischemia, sponsored by Biosensors Europe SA. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-15.

Sponsored by Biosensors Europe SA (part of Blue Sail Medical Co., Ltd.) · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,098
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Coronary Artery Stenoses
  • Stable Angina
  • Ischemia
  • NSTEMI - Non-ST Segment Elevation MI
  • STEMI
03

In context

Coronary Stenosis

326 studies on the registry are indexed under Coronary Stenosis; 57 are open to participants now.

This study's enrollment of 2,098 is above the median of 200 across 125 observational studies indexed under Coronary Stenosis.

Browse Coronary Stenosis studies →

Lead sponsor

Biosensors Europe SA is the lead sponsor of 24 studies on the registry; 3 are open to participants now.

First submitted before Biosensors Europe SA became part of Blue Sail Medical Co., Ltd..

Browse Biosensors Europe SA studies →All Blue Sail Medical Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • "Real world, all comer" patients

    1. Age ≥18 years;
    2. Patients that need a treatment with a BioMatrix Flex™ drug- eluting stent or a BioMatrix NeoFlex™drug-eluting stent;
    3. 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;
    4. No limitation on the number of treated lesions, vessels, and lesion length, within the limits of social security reimbursements;
    5. Patient with DAPT indication after PCI.

Exclusion criteria

Exclusion Criteria:

  1. Inability to provide ;
  2. Patients needing additional stent NOT of the BioMatrix Flex™ or NeoFlex™ types;
  3. Patients receiving next to the BioMatrix Flex™ or BioMatrix NeoFlex™ also other coronary vascular interventions, for example, balloon dilation;
  4. Pregnant or planning to become pregnant patient;
  5. DES and BMS implantation less than 6 months before screening;
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,098 participants (actual)
Target follow-up
2 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

Secondary outcomes

  1. Primary and secondary stent thrombosis

    Primary and secondary stent thrombosis (definite and probable according to ARC definitions) at 6 months and 2 years;

    Time frame: 6 months and 2 years

  2. Major bleeding

    Major bleeding (BARC 3, 4 and 5 definitions) at 6 months and 2 years

    Time frame: 6 months and 2 years

  3. 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

    Time frame: 2 years

  4. Cardiac deaths at 6 months and and 2 years

    Cardiac deaths at 6 months and and 2 years

    Time frame: 6 months and and 2 years

  5. 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

    Time frame: 6 months and 2 years

  6. Death,MI and cerebrovascular accidents at 6 months and 2 years

    Death,MI and cerebrovascular accidents at 6 months and 2 years

    Time frame: 6 months and 2 years

  7. 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

    Time frame: 6 months and 2 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Not planned

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2014 to primary completion in Apr 2018, 49 months.

Of 58 observational studies under Coronary Stenosis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 143. This study's 49 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2018
First posted
Mar 12, 2018
StartActual
Mar 6, 2014
Primary completionActual
Apr 9, 2018
CompletionActual
Oct 31, 2019
Last update
Apr 15, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 15, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03461484
Lead sponsor
Biosensors Europe SA
Collaborators
European Cardiovascular Research Center
Responsible party
Sponsor
First posted
Mar 12, 2018
Start date
Mar 6, 2014
Primary completion
Apr 9, 2018
Completion
Oct 31, 2019
Last update
Apr 15, 2020

Study contacts

Christian Spaulding, MD
principal investigator · Hôpital Européen Georges-Pompidou
Lanusz Lipiecki, MD
principal investigator · Clinique des Dômes

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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