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BioFreedom French Registry

23. april 2021 opdateret af: Biosensors Europe SA

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

1500

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
DOCE
Tidsramme: 1 year
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
All-cause mortality
Tidsramme: 12-month and 24-month
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
Tidsramme: 12 months and 2 years
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
Tidsramme: 12 months and 2 years
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
Tidsramme: 12 months 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
Tidsramme: 12 months 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
Tidsramme: 12 months 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
Tidsramme: Inclusion, 12 months and 24 months
Clinically driven TLR at any follow-up time point
Inclusion, 12 months and 24 months
Clinically driven TVR at any follow-up time point
Tidsramme: Inclusion, 12 months and 24 months
Clinically driven TVR at any follow-up time point
Inclusion, 12 months and 24 months
Any revascularization
Tidsramme: within 24 months following the index procedure
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.
Tidsramme: Inclusion, 12 months and 24 months
Stroke, disabling and non-disabling.
Inclusion, 12 months and 24 months
BARC 3 to 5 bleeding
Tidsramme: Inclusion, 12 months and 24 months
BARC 3 to 5 bleeding
Inclusion, 12 months and 24 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Biosensors Europe SA

Samarbejdspartnere

European Cardiovascular Research Center

Efterforskere

  • Ledende efterforsker: Janusz Lipiecki, MD, Clinique Des Dômes
  • Ledende efterforsker: Philippe Garot, MD, ICPS, Massy

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. april 2019

Primær færdiggørelse (Forventet)

30. april 2021

Studieafslutning (Forventet)

27. april 2022

Datoer for studieregistrering

Først indsendt

5. november 2018

Først indsendt, der opfyldte QC-kriterier

15. november 2018

Først opslået (Faktiske)

19. november 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. april 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 18-EU-01

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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