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Opsens Optowire for Fractional Flow Reserve - The O2 Pilot Study (O2)

9. juli 2015 opdateret af: Olivier F. Bertrand, Laval University
The purpose of this study is to assess the usability and safety of the Opsens OptoWire and Optomonitor in measuring fractional flow reserve (FFR) in patients with coronary artery disease who are undergoing a coronary angiogram.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Fractional flow reserve (FFR) measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximum flow in a normal coronary artery. An FFR of 1.0 is widely accepted as normal. An FFR value lower than 0.75 - 0.80 is generally considered to be associated with myocardial ischemia (MI).

FFR is easily measured during routine coronary angiography by using a pressure wire to calculate the ratio between coronary pressure distal to a coronary artery stenosis and aortic pressure under conditions of maximum myocardial hyperemia. This ratio represents the potential decrease in coronary flow distal to the coronary stenosis.

Over the past decade, FFR measurement has been increasingly used in cardiac catheterization laboratories. It provides a quantitative assessment of the functional severity of a coronary artery stenosis identified during coronary angiography and cardiac catheterization.

Opsens, Inc. has developed a new pressure wire for use in determining FFR in coronary arteries; the OptoWire. The OptoWire is an instrumented guide wire with a fiber optic pressure sensor mounted 3.5 cm proximal to the tip. The Optowire measures blood pressure during diagnostic and/or interventional procedures when used in combination with the OptoMonitor.

The O2 study is a pilot study which aims to provide preliminary experience in human patients with coronary artery disease. The study data will also be used as part of design validation.

The O2 study is a prospective single arm study designed to assess the usability, functionality, and safety of the Optowire and Optomonitor in patients.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Canada
      • Quebec, Canada, G1V 4G5
        • IUCPQ - Laval Hospital

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients with

    • Stable angina or,
    • Unstable angina pectoris or,
    • Atypical chest pain or no chest pain but with suspected ischemia
  • At least one moderate lesion in native coronary artery thought to produce ischemia
  • Operator and patient agree for procedures
  • Patient (> 18 years) has signed a written informed consent prior to procedure

Exclusion Criteria:

  • Lesions with angiographic 'haziness' or suspected to contain thrombus
  • Post-coronary artery bypass grafting
  • Total occlusion
  • If use of atherectomy device is indicated

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Fractional flow reserve
Fractional flow reserve measurement
Enhed: Fractional flow reserve measurement
Fractional flow reserve measurement
Andre navne:
  • Opsens Optowire and Optomonitor

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety and handling assessment of the Optowire
Tidsramme: Patients will be followed through removal of the OptoWire from percutaneous insertion site and completion of the cardiac catheterization procedure (expected average <1hr)
  1. Safely reach and cross a target lesion;
  2. perform an FFR measurement using the Optowire and Optomonitor according to the product user guide;
  3. disconnect the proximal connector on the OptoWire during the procedure, placing an interventional device (if necessary), and reconnecting the Optowire proximal connector;
  4. safely remove the Optowire from the coronary artery.

Dedicated questionnaires will be used for such assessment
Patients will be followed through removal of the OptoWire from percutaneous insertion site and completion of the cardiac catheterization procedure (expected average <1hr)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Comparison of FFR values measured with Optowire vs. with FFR guide wire used in standard practice
Tidsramme: Patients will be followed through removal of the OptoWire from percutaneous insertion site and completion of the cardiac catheterization procedure (expected average <1hr)
In selected cases, the operator may choose to perform FFR measurements using currently approved FFR wires. Values obtained with standard FFR wires and Optowire may therefore be compared.
Patients will be followed through removal of the OptoWire from percutaneous insertion site and completion of the cardiac catheterization procedure (expected average <1hr)

Samarbejdspartnere og efterforskere

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

Sponsor

Laval University

Samarbejdspartnere

Opsens, Inc.
International Chair on Interventional Cardiology and Transradial Approach

Efterforskere

  • Ledende efterforsker: Olivier F Bertrand, MD PhD, International Chair on Interventional Cardiology and Transradial Approach

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

1. maj 2014

Primær færdiggørelse (Faktiske)

1. maj 2015

Studieafslutning (Faktiske)

1. maj 2015

Datoer for studieregistrering

Først indsendt

15. maj 2014

Først indsendt, der opfyldte QC-kriterier

16. maj 2014

Først opslået (Skøn)

21. maj 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. juli 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juli 2015

Sidst verificeret

1. juli 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • O2 Pilot Study

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Kosttilskud

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Placeringer

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