e-BioMatrix 6 Month DAPT France

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2098 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-06

Study Completion Date

2019-10-31

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No