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Clinical Usefulness of Fractional Flow Reserve Measurement for Significant Stenosis in Proximal Coronary Artery

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT02475291
Collaborator
(none)
26
Enrollment
1
Location
11
Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Fractional flow reserve (FFR) is a pressure-wire-based index that is used during coronary angiography to assess the potential of a coronary stenosis to induce myocardial ischemia. Recent ESC guidelines referred to the usefulness of FFR extensively when noninvasive stress imaging is contraindicated, non-diagnostic, or unavailable. However, FFR requires additional manipulation with maximal and stable hyperemia by intravenous adenosine. More routine use of FFR for all angiographically significant stenoses would add considerable time, cost, and complexity to each PCI procedure and might also increase the risk of catheter-related complications such as coronary dissection and perforation. Although the guideline mentioned that FFR may not be useful in very high grade lesions (angiographically >90%) which always have an FFR <0.80, it have not been revealed yet proper criteria to predict FFR <0.80 obtained by angiographic parameters including degree of stenosis, lesion location and vessel size. It would be valuable to find more precise criteria available by conventional angiography for discrimination of functional stenosis in way to reduce the risk of additional procedure. For the purpose, the investigators will perform FFR in the lesions with significant stenosis (>70% diameter stenosis by visual estimation) and compare the angiographic parameters and FFR values in the study.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    26 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Study Start Date :
    Jun 1, 2015
    Actual Primary Completion Date :
    Mar 1, 2016
    Actual Study Completion Date :
    May 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Significant coronary lesions

    Significant lesions with more than 70% diameter stenosis at proximal major coronary arteri(es).

    Outcome Measures

    Primary Outcome Measures

    1. Agreement of diagnosis between FFR-documented ischemia and angiographically significant stenosis [1day]

      Coronary lesions with FFR <0.80 will be defined to be related with ischemia. Because all lesions in the study will be angiographically significant stenosis with DS >70%, agreement of diagnosis between FFR-defined ischemia and angiographically significant stenosis will be obtained by the ratio of lesions with FFR <0.80.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients ≥ 19 years old

    • Typical angina

    • Stable or unstable angina pectoris

    • At least one or more major epicardial coronary arteries with significant stenosis (>70% diameter stenosis by visual estimation on angiogram) confined to the proximal portion of left anterior descending artery, left circumflex artery, or right coronary artery

    • Reference vessel diameter of target lesion ≥3.0 mm

    • Normal LV ejection fraction (≥50%) without wall motion abnormality by echocardiography

    Exclusion Criteria:

    • Previous myocardial infarction

    • Previous coronary bypass graft surgery

    • Cardiogenic shock

    • Multiple lesions in the vessel of interest

    • Contraindication or hypersensitivity to adenosine or contrast media

    • Reduced coronary blood flow (TIMI flow grade <3) in the vessel of interest

    • Heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesions

    • Pregnant women or women with potential childbearing

    • Inability to understand or read the informed content

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine Seoul Korea, Republic of 120-752

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT02475291
    Other Study ID Numbers:
    • 1-2015-0025
    First Posted:
    Jun 18, 2015
    Last Update Posted:
    Jul 27, 2016
    Last Verified:
    Jul 1, 2016
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Constriction, Pathologic

    Study Results

    No Results Posted as of Jul 27, 2016