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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    500
  • sponsor
    Diagram B.V.
Updated on 19 February 2024
stenosis
bypass graft
angiography
percutaneous coronary intervention
coronary artery stenosis
hyperemia

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.

Details
Condition Coronary Artery Disease, Coronary Artery Disease, Coronary heart disease
Age 18-100 years
Treatment RFR guided CABG, Angio guided CABG
Clinical Study IdentifierNCT04375306
SponsorDiagram B.V.
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Previous CABG
Concomitant severe valvular disease intervention
Remaining (expected) coronary stenosis of > 50% diameter stenosis distally to graft anastomosis
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
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