Clinical trial NCT03745066: BioFreedom French Registry
Official title: A Post-Market Registry of the BioFreedomTM Biolimus A9TM Coated Coronary Stent System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
Lead sponsor: Biosensors Europe SA
Sponsor class: INDUSTRY
Collaborators: name: European Cardiovascular Research Center
First posted: 2018-11-19
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This observational registry is open to all patients with coronary artery disease treated by percutaneous coronary intervention (PCI) with one or more BioFreedom™ DCS within the indications of the Instructions for Use.

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.

Eligibility criteria: 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

Primary outcomes:
measure: DOCE
timeFrame: 1 year
Secondary outcomes:
measure: All-cause mortality
timeFrame: 12-month and 24-month
measure: Patient-oriented composite endpoint (POCE) at 12 and 24 months
timeFrame: 12 months and 2 years
measure: Composite of Cardiovascular Death (CD) at 12 and 24 months
timeFrame: 12 months and 2 years
measure: Definite/probable ST at 12 and 24 months
timeFrame: 12 months and 24 months
measure: Target Vessel Failure defined at 12 and 24 months
timeFrame: 12 months and 24 months
measure: Target Lesion Failure at 12 and 24 months
timeFrame: 12 months and 24 months
measure: Clinically driven TLR at any follow-up time point
timeFrame: Inclusion, 12 months and 24 months
measure: Clinically driven TVR at any follow-up time point
timeFrame: Inclusion, 12 months and 24 months
measure: Any revascularization
timeFrame: within 24 months following the index procedure
measure: Stroke, disabling and non-disabling.
timeFrame: Inclusion, 12 months and 24 months
measure: BARC 3 to 5 bleeding
timeFrame: Inclusion, 12 months and 24 months
Other outcomes:
Locations:
city: Clermont-ferrand
country: France
facility: Clinique Des Dômes
state: Cedex 2
city: Quincy sous Sénart
country: France
facility: at Hôpital Privé Claude Galien ICPS
state: Essonne
city: Fontaine-lès-Dijon
country: France
facility: Clinique de Fontaine
city: Haguenau Cedex
country: France
facility: Centre Hospitalier General
city: Pessac
country: France
facility: Clinique Saint Martin
city: Toulouse
country: France
facility: CHU Toulouse Rangeuil
Study officials:
affiliation: Clinique des Dômes
name: Janusz Lipiecki, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ICPS, Massy
name: Philippe Garot, MD
role: PRINCIPAL_INVESTIGATOR
References: