Resting Full-cycle Flow Ratio (RFR) Versus Angiography to Guide Revascularization Strategy in Patients Undergoing Coronary Artery By-pass Grafting (CABG)
Recruiting now · Not applicable
Conditions studied: Coronary Artery Disease
In brief
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.
Key facts
- Study ID
- NCT04375306
- Run by
- Diagram B.V.
- People needed
- 500
- Starts
- 2020-02-03
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2024-02-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All patients between 18 or older undergoing CABG
- Patients willing and capable to provide written informed consent
You may not qualify if…
- 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
Where it is running
- Imelda ziekenhuis — Bonheiden, Belgium (enrolling)
- Medical University of Silesia — Katowice, Poland (enrolling)
- SUSCCH — Banská Bystrica, Slovakia (enrolling)
- AZ Sint-Jan Brugge — Bruges, Belgium
Full record on ClinicalTrials.gov
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