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Completed

NCT Number: NCT03461484

e-BioMatrix 6 Month DAPT France

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.

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Key information

Conditions

Coronary Artery Stenoses Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Coronary Disease Coronary Stenosis Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia NSTEMI - Non-ST Segment Elevation MI Necrosis Neurologic Manifestations Non-ST Elevated Myocardial Infarction Pain Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction STEMI Signs and Symptoms Stable Angina Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • "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.

Exclusion criteria

  • 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;

Treatment and study plan

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

    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

Secondary outcomes

  1. Primary and secondary stent thrombosis

    Time frame: 6 months and 2 years

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

  2. Major bleeding

    Time frame: 6 months and 2 years

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

  3. Major adverse cardiac and cerebrovascular events (MACCEs) in the overall population

    Time frame: 2 years

    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

  4. Cardiac deaths at 6 months and and 2 years

    Time frame: 6 months and and 2 years

    Cardiac deaths at 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

    Time frame: 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

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

    Time frame: 6 months and 2 years

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

  7. Death, post-procedural 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

Sponsors and collaborators

Lead sponsor

Biosensors Europe SA

Industry

Collaborators

  • European Cardiovascular Research Center

Registry information

Official study title

A French Post-market Observational/Non-interventional Study of the BioMatrix Flex™ and BioMatrix Neo Flex™ Drug Eluting Stents With 6-month DAPT

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Mar 12, 2018
Registry last updated
Apr 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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