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Fractional Flow Reserve (FFR) Versus Instant Wave-Free Ratio (iFR)

Sponsor
NHS National Waiting Times Centre Board (Other)
Overall Status
Completed
CT.gov ID
NCT01559493
Collaborator
Golden Jubilee National Hospital (Other), Catharina Ziekenhuis Eindhoven (Other), Onze Lieve Vrouw Hospital (Other), Stockholm South General Hospital (Other), Brno University Hospital (Other), Stanford University (Other)
200
Enrollment
5
Locations
1
Duration (Months)
40
Patients Per Site
39.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparison of Fractional Flow Reserve versus instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice

  • To compare FFR to iFR in arbitrary consecutive patients referred for percutaneous coronary intervention (PCI).

  • To investigate the influence of hyperemia on iFR.

  • To test reproducibility of iFR and FFR.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comparison of Fractional Flow Reserve Versus Instant Wave-Free Ratio for Assessment of Coronary Artery Stenosis Severity in Routine Practice
    Study Start Date :
    Jan 1, 2012
    Actual Primary Completion Date :
    Feb 1, 2012
    Actual Study Completion Date :
    Feb 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    FFR; iFR

    Interventional Cardiology, Pressure wire, fractional flow reserve, coronary flow measurement

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of Fractional Flow Reserve vs. instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice [30 days]

      In this prospective, multicenter, international investigation, all consecutive patients in 5 centers, referred for PCI will be included. FFR will be submitted for one vessel in each patient - this will be the first vessel in which the FFR is performed. Measurements will be performed in duplicate. iFR will be calculated for all lesions for which an FFR measurement is submitted. In addition, iFR and FFR will be compared retrospectively in 1000 patients who had FFR measurements in the recent past

    Secondary Outcome Measures

    1. iFR at rest vs iFr during hyperemia [30 days]

      iFR is said to be independent of hyperemia. Accordingly a secondary outcome of this study will be a paired comparison of iFR at rest vs iFr with adenosine induced hyperemia.

    2. Repeatability of iFr and FFR [30 days]

      To test repeatability of iFR and FFR

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • all consecutive patients undergoing FFR assessment for standard clinical indications.
    Exclusion Criteria:

    • prior CABG

    • extremely tortuous, calcified lesions

    • coronary artery occlusion

    • acute MI within 5 days

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University Stanford California United States
    2 Cardiovascular Center Aalst Aalst Belgium
    3 University Hospital Brno Brno Czech Republic
    4 Catharina Ziekenhuis Eindhoven Netherlands
    5 Stockholm South Hospital Stockholm Sweden

    Sponsors and Collaborators

    • NHS National Waiting Times Centre Board
    • Golden Jubilee National Hospital
    • Catharina Ziekenhuis Eindhoven
    • Onze Lieve Vrouw Hospital
    • Stockholm South General Hospital
    • Brno University Hospital
    • Stanford University

    Investigators

    • Principal Investigator: Prof Keith G. Oldroyd, Golden Jubilee National Hospital
    • Principal Investigator: Prof Colin Berry, MD, Golden Jubilee National Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Keith G. Oldroyd, Consultant Cardiologist, NHS National Waiting Times Centre Board
    ClinicalTrials.gov Identifier:
    NCT01559493
    Other Study ID Numbers:
    • Version F 2nd Jan 2012
    First Posted:
    Mar 21, 2012
    Last Update Posted:
    Mar 21, 2012
    Last Verified:
    Mar 1, 2012
    Keywords provided by Prof. Keith G. Oldroyd, Consultant Cardiologist, NHS National Waiting Times Centre Board
    atherosclerotic lesion assessment
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Plaque, Atherosclerotic

    Study Results

    No Results Posted as of Mar 21, 2012