Clinical trial NCT03461484: e-BioMatrix 6 Month DAPT France
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Stenoses
Stable Angina
Ischemia
NSTEMI - Non-ST Segment Elevation MI
STEMI
Lead sponsor: Biosensors Europe SA
Sponsor class: INDUSTRY
Collaborators: name: European Cardiovascular Research Center
First posted: 2018-03-12
Enrollment: 2098
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.


Eligibility criteria: 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:

1. Inability to provide informed consent;
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;

Primary outcomes:
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
timeFrame: 6 months
Secondary outcomes:
measure: Primary and secondary stent thrombosis
timeFrame: 6 months and 2 years
measure: Major bleeding
timeFrame: 6 months and 2 years
measure: Major adverse cardiac and cerebrovascular events (MACCEs) in the overall population
timeFrame: 2 years
measure: Cardiac deaths at 6 months and and 2 years
timeFrame: 6 months and and 2 years
measure: 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
timeFrame: 6 months and 2 years
measure: Death,MI and cerebrovascular accidents at 6 months and 2 years
timeFrame: 6 months and 2 years
measure: Death, post-procedural MI and cerebrovascular accidents at 6 months and 2 years
timeFrame: 6 months and 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Hôpital Européen Georges-Pompidou
name: Christian Spaulding, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique des Dômes
name: Lanusz Lipiecki, MD
role: PRINCIPAL_INVESTIGATOR
References: