BioFreedom French Registry

A Post-Market Registry of the BioFreedomTM Biolimus A9TM Coated Coronary Stent System

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease

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 Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

Study Locations

• France
  • Fontaine-lès-Dijon, France, 21121
    • Clinique de Fontaine
  • Haguenau Cedex, France, 67504
    • Centre Hospitalier General
  • Pessac, France, 33600
    • Clinique Saint Martin
  • Toulouse, France
    • CHU Toulouse Rangeuil
  • Cedex 2
    • Clermont-ferrand, Cedex 2, France, 63050
      • Clinique Des Dômes
  • Essonne
    • Quincy sous Sénart, Essonne, France, 91480
      • at Hôpital Privé Claude Galien ICPS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DOCE	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).	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	1. All-cause mortality, CD, non-cardiovascular and undetermined death in hospital and at 12 and 24 months	12-month and 24-month
Patient-oriented composite endpoint (POCE) at 12 and 24 months	Patient-oriented composite endpoint (POCE) at 12 and 24 months defined as all-cause mortality, any stroke, any MI (including nontarget vessel territory) and any revascularization.	12 months and 2 years
Composite of Cardiovascular Death (CD) at 12 and 24 months	Composite of CD, MI and definite/probable stent thrombosis (ST) at 12 and 24 months.	12 months and 2 years
Definite/probable ST at 12 and 24 months	Definite/probable ST at 12 and 24 months	12 months and 24 months
Target Vessel Failure defined at 12 and 24 months	Target Vessel Failure (TVF) defined as CD, target-vessel-related MI, and Target vessel revascularization (TVR) at 12 and 24 months	12 months and 24 months
Target Lesion Failure at 12 and 24 months	Target Lesion Failure (TLF) defined as CD, target-vessel-related MI, and clinically driven TLR at 12 and 24 months	12 months and 24 months
Clinically driven TLR at any follow-up time point	Clinically driven TLR at any follow-up time point	Inclusion, 12 months and 24 months
Clinically driven TVR at any follow-up time point	Clinically driven TVR at any follow-up time point	Inclusion, 12 months and 24 months
Any revascularization	Any revascularization within 24 months following the index procedure, unless they are planned within the 1st month	within 24 months following the index procedure
Stroke, disabling and non-disabling.	Stroke, disabling and non-disabling.	Inclusion, 12 months and 24 months
BARC 3 to 5 bleeding	BARC 3 to 5 bleeding	Inclusion, 12 months and 24 months

Collaborators and Investigators

• Sponsor: Biosensors Europe SA
• Collaborators: European Cardiovascular Research Center
• Investigators: Principal Investigator: Janusz Lipiecki, MD, Clinique Des Dômes; Principal Investigator: Philippe Garot, MD, ICPS, Massy

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2019
• Primary Completion (Anticipated): April 30, 2021
• Study Completion (Anticipated): April 27, 2022

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (Actual): November 19, 2018

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 23, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: coronary artery disease
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 18-EU-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No