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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03461484
Other study ID # 13-EU-02
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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;

Study Design


Related Conditions & MeSH terms


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
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