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

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Recruiting
participants needed

500
sponsor

Diagram B.V.

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Updated on 19 February 2024

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stenosis

bypass graft

angiography

percutaneous coronary intervention

coronary artery stenosis

hyperemia

Summary

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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	18years - 100years
Treatment	RFR guided CABG, Angio guided CABG
Clinical Study Identifier	NCT04375306
Sponsor	Diagram B.V.
Last Modified on	19 February 2024

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