Resting Full-cycle Flow Ratio (RFR) Versus Angiography to Guide Revascularization Strategy in Patients Undergoing Coronary Artery By-pass Grafting (CABG)

Last updated: January 31, 2024
Sponsor: Diagram B.V.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Cardiovascular Disease

Heart Disease

Treatment

RFR guided CABG

Angio guided CABG

Clinical Study ID

NCT04375306
9333
  • Ages > 18
  • All Genders

Study Summary

Different trials have shown that fractional flow reserve (FFR) could successfully guide revascularization in patients undergoing percutaneous coronary intervention (PCI).

It is conceivable that a similar revascularization guidance could be useful also for surgical revascularization i.e. coronary by-pass graft (CABG). Experience learns that grafts placed on vessels with hemodynamically non-significant stenosis often occlude due to competitive antegrade flow.

Resting full-cycle Flow Ratio (RFR) is a measurement performed to evaluate the hemodynamic severity of coronary stenosis. Differently from FFR which is a measurement performed in maximal hyperemia, the RFR is a measurement that is performed in rest and therefore may predict better than FFR the baseline equilibriums that could lead to graft failure, while it has similar capacity to identify hemodynamically significant stenosis as FFR. It is unknown whether RFR guided CABG revascularization is superior as compared to angiography alone.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patients between 18 or older undergoing CABG
  • Patients willing and capable to provide written informed consent

Exclusion

Exclusion Criteria:

  • Previous CABG
  • Concomitant severe valvular disease intervention
  • Remaining (expected) coronary stenosis of > 50% diameter stenosis distally to graftanastomosis
  • Left ventricular ejection fraction <30%
  • Known transmural myocardial infarction
  • Documented microvascular disease
  • RFR/FFR measurement judged impossible
  • Life expectancy <2 years
  • Participation in other investigational clinical trials

Study Design

Total Participants: 500
Treatment Group(s): 2
Primary Treatment: RFR guided CABG
Phase:
Study Start date:
February 03, 2020
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Imelda ziekenhuis

    Bonheiden,
    Belgium

    Active - Recruiting

  • AZ Sint-Jan Brugge

    Brugge,
    Belgium

    Site Not Available

  • Medical University of Silesia

    Katowice,
    Poland

    Active - Recruiting

  • SUSCCH

    Banská Bystrica,
    Slovakia

    Active - Recruiting

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