e-BioMatrix 6 Month DAPT France

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.

Study Overview

• Status: Completed
• Conditions: Ischemia; Stable Angina; STEMI; NSTEMI - Non-ST Segment Elevation MI; Coronary Artery Stenoses

• Study Type: Observational
• Enrollment (Actual): 2098

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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;

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary and secondary stent thrombosis	Primary and secondary stent thrombosis (definite and probable according to ARC definitions) at 6 months and 2 years;	6 months and 2 years
Major bleeding	Major bleeding (BARC 3, 4 and 5 definitions) at 6 months and 2 years	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	2 years
Cardiac deaths at 6 months and and 2 years	Cardiac deaths at 6 months and and 2 years	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	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	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	6 months and 2 years

Collaborators and Investigators

• Sponsor: Biosensors Europe SA
• Collaborators: European Cardiovascular Research Center
• Investigators: Principal Investigator: Christian Spaulding, MD, Hopital Europeen Georges-Pompidou; Principal Investigator: Lanusz Lipiecki, MD, Clinique Des Dômes

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2014
• Primary Completion (Actual): April 9, 2018
• Study Completion (Actual): October 31, 2019

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (Actual): March 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 15, 2020
• Last Update Submitted That Met QC Criteria: April 14, 2020
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Coronary Disease; Chest Pain; Angina Pectoris; Ischemia; Angina, Stable; Coronary Stenosis
• Other Study ID Numbers: 13-EU-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not planned

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No