NCT03745066

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

April 4, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2022

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

2.1 years

First QC Date

November 5, 2018

Last Update Submit

April 23, 2021

Conditions

Coronary Artery Disease

Keywords

coronary artery disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • 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

  • +6 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Clinique Des Dômes

Clermont-Ferrand, Cedex 2, 63050, France

Location

at Hôpital Privé Claude Galien ICPS

Quincy-sous-Sénart, Essonne, 91480, France

Location

Clinique de Fontaine

Fontaine-lès-Dijon, 21121, France

Location

Centre Hospitalier General

Haguenau, 67504, France

Location

Clinique Saint Martin

Pessac, 33600, France

Location

CHU Toulouse Rangeuil

Toulouse, France

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Janusz Lipiecki, MD

    Clinique des Dômes

    PRINCIPAL INVESTIGATOR

  • Philippe Garot, MD

    ICPS, Massy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2018

First Posted

November 19, 2018

Study Start

April 4, 2019

Primary Completion

April 30, 2021

Study Completion

April 27, 2022

Last Updated

April 26, 2021

Record last verified: 2021-04

Locations

FR(6)