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Coronary Artery DiseaseNCT03745066

BioFreedom French Registry

An observational study of Coronary Artery Disease, run by Biosensors Europe SA at 6 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Coronary Artery Disease
How many people
1,500 participants
Where
6 sitesFrance
Study dates
4 Apr 2019to 27 Apr 2022
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • Clinique Des Dômes

    Clermont-Ferrand, Cedex 2, 63050

  • Clinique de Fontaine

    Fontaine-lès-Dijon, 21121

  • Centre Hospitalier General

    Haguenau, 67504

  • Clinique Saint Martin

    Pessac, 33600

  • at Hôpital Privé Claude Galien ICPS

    Quincy-sous-Sénart, Essonne, 91480

  • CHU Toulouse Rangeuil

    Toulouse

Other trials in France

About this study

Official title: 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.

Read the 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.

Keywords
coronary artery disease
Medical subject headings
Coronary Artery Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 1 year

Secondary outcomes (11)

  1. All-cause mortality

    1. All-cause mortality, CD, non-cardiovascular and undetermined death in hospital and at 12 and 24 months

    Measured: 12-month and 24-month

  2. 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.

    Measured: 12 months and 2 years

  3. 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.

    Measured: 12 months and 2 years

  4. Definite/probable ST at 12 and 24 months

    Definite/probable ST at 12 and 24 months

    Measured: 12 months and 24 months

  5. 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

    Measured: 12 months and 24 months

  6. 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

    Measured: 12 months and 24 months

  7. Clinically driven TLR at any follow-up time point

    Clinically driven TLR at any follow-up time point

    Measured: Inclusion, 12 months and 24 months

  8. Clinically driven TVR at any follow-up time point

    Clinically driven TVR at any follow-up time point

    Measured: Inclusion, 12 months and 24 months

  9. Any revascularization

    Any revascularization within 24 months following the index procedure, unless they are planned within the 1st month

    Measured: within 24 months following the index procedure

  10. Stroke, disabling and non-disabling.

    Stroke, disabling and non-disabling.

    Measured: Inclusion, 12 months and 24 months

  11. BARC 3 to 5 bleeding

    BARC 3 to 5 bleeding

    Measured: Inclusion, 12 months and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2018
  2. Study start4 Apr 2019
  3. Primary completion30 Apr 2021 (estimated)
  4. Study completion27 Apr 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03745066
Sponsor's protocol ID
18-EU-01
Status last verified
Apr 2021
First submitted
5 Nov 2018
Last updated
26 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Biosensors Europe SA at 6 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DOCE (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03745066.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.

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