Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-03-14 @ 6:44 PM
Study NCT ID:
NCT03745066
Status:
UNKNOWN
Last Update Posted:
2021-04-26
First Post:
2018-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BioFreedom French Registry
Sponsor:
Biosensors Europe SA
Organization:
Study Overview
Official Title:
A Post-Market Registry of the BioFreedomTM Biolimus A9TM Coated Coronary Stent System
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: