BioFreedom French Registry

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03745066
• Other study ID #: 18-EU-01
• Status: Active, not recruiting
• Start date: April 4, 2019
• Est. completion date: April 27, 2022

Study information

• Verified date: April 2021
• Source: Biosensors Europe SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: April 27, 2022
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
France	Clinique Des Dômes	Clermont-ferrand	Cedex 2
France	Clinique de Fontaine	Fontaine-lès-Dijon
France	Centre Hospitalier General	Haguenau Cedex
France	Clinique Saint Martin	Pessac
France	at Hôpital Privé Claude Galien ICPS	Quincy sous Sénart	Essonne
France	CHU Toulouse Rangeuil	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Biosensors Europe SA	European Cardiovascular Research Center

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Definite/probable ST at 12 and 24 months	Definite/probable ST at 12 and 24 months	12 months and 24 months
Secondary	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
Secondary	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
Secondary	Clinically driven TLR at any follow-up time point	Clinically driven TLR at any follow-up time point	Inclusion, 12 months and 24 months
Secondary	Clinically driven TVR at any follow-up time point	Clinically driven TVR at any follow-up time point	Inclusion, 12 months and 24 months
Secondary	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
Secondary	Stroke, disabling and non-disabling.	Stroke, disabling and non-disabling.	Inclusion, 12 months and 24 months
Secondary	BARC 3 to 5 bleeding	BARC 3 to 5 bleeding	Inclusion, 12 months and 24 months