e-BioMatrix 6 Month DAPT France

Ischemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03461484
• Other study ID #: 13-EU-02
• Status: Completed
• Start date: March 6, 2014
• Est. completion date: October 31, 2019

Study information

• Verified date: May 2019
• Source: Biosensors Europe SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2098
• Est. completion date: October 31, 2019
• Est. primary completion date: April 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Biosensors Europe SA	European Cardiovascular Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Major bleeding	Major bleeding (BARC 3, 4 and 5 definitions) at 6 months and 2 years	6 months and 2 years
Secondary	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
Secondary	Cardiac deaths at 6 months and and 2 years	Cardiac deaths at 6 months and and 2 years	6 months and and 2 years
Secondary	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
Secondary	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
Secondary	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