e-BioMatrix 6 Month DAPT France

NCT03461484 | Completed DMC

• 1 other identifier: 13-EU-02
• Study Type: observational
• Target: 2,098
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

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

  6 months

Secondary Outcomes (7)

• Primary and secondary stent thrombosis

  6 months and 2 years

• Major bleeding

  6 months and 2 years

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

  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

  6 months and 2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• "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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Biosensors Europe SA: lead
• European Cardiovascular Research Center: collaborator

MeSH Terms

Conditions

Coronary Stenosis; Angina, Stable; Ischemia; Non-ST Elevated Myocardial Infarction; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Myocardial Infarction; Infarction; Necrosis

Study Officials

• Christian Spaulding, MD

  Hôpital Européen Georges-Pompidou

  PRINCIPAL INVESTIGATOR

• Lanusz Lipiecki, MD

  Clinique des Dômes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 12, 2018
• Study Start: March 6, 2014
• Primary Completion: April 9, 2018
• Study Completion: October 31, 2019
• Last Updated: April 15, 2020

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share