A Post-Market Registry of the BioFreedomTM Biolimus A9TM Coated Coronary Stent System
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Biosensors Europe SA
- Enrollment
- 1,500
- Locations
- 6
- Primary Endpoint
- DOCE
Study Overview
Brief Summary
Prospective, observational multi-center registry to be conducted at up to 25 French interventional cardiology centers. Patients will be eligible once they have received at least one BioFreedomTM DCS as per standard clinical practice and will be followed for up to 2 years post PCI for data collection.
The purpose of the registry is to explore the safety and effectiveness of the BioFreedomTM DCS in standard clinical practice in France and to serve as part of Post Market Surveillance.
Detailed Description
Prospective, observational multi-center registry to be conducted at up to 25 French interventional cardiology centers. Patients will be eligible once they have received at least one BioFreedomTM DCS as per standard clinical practice and will be followed for up to 2 years post PCI for data collection.
The registry will be purely observational and will not interfere with physician's decisions relating to stent selection or indication for treatment.
The purpose of the registry is to explore the safety and effectiveness of the BioFreedomTM DCS in standard clinical practice in France and to serve as part of Post Market Surveillance.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients treated with one or more BioFreedom™ DCS .Patients who agree to comply with the follow up requirements. .Patients with a life expectancy of > 1 year at time of consent. .Patients eligible to receive dual anti platelet therapy (DAPT).
- •Patients who have signed an Informed Consent
Exclusion Criteria
- •Patients unable or unwilling to give documented informed consent
- •Patients taking part in another interventional trial which has not completed follow-up for the primary endpoint .Patient has received an additional stent different from a BioFreedom™ DCS stent during the index procedure.
- •Pregnant or breastfeeding women
- •Planned surgery within 6 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri surgical period for non HBR patients
- •Planned surgery within 1 month of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri surgical period for HBR patients
- •Patients under judicial protection, tutorship or curatorship
Outcomes
Primary Outcomes
DOCE
Time Frame: 1 year
Device-oriented composite endpoint (DOCE) at 12 months defined as composite of cardiovascular death (CD), myocardial infarction (MI) not clearly attributable to a non-target vessel and clinically driven target lesion revascularization (cd-TLR).
Secondary Outcomes
- All-cause mortality(12-month and 24-month)
- Patient-oriented composite endpoint (POCE) at 12 and 24 months(12 months and 2 years)
- Composite of Cardiovascular Death (CD) at 12 and 24 months(12 months and 2 years)
- Definite/probable ST at 12 and 24 months(12 months and 24 months)
- Target Vessel Failure defined at 12 and 24 months(12 months and 24 months)
- Target Lesion Failure at 12 and 24 months(12 months and 24 months)
- Clinically driven TLR at any follow-up time point(Inclusion, 12 months and 24 months)
- Clinically driven TVR at any follow-up time point(Inclusion, 12 months and 24 months)
- Any revascularization(within 24 months following the index procedure)
- Stroke, disabling and non-disabling.(Inclusion, 12 months and 24 months)
- BARC 3 to 5 bleeding(Inclusion, 12 months and 24 months)