Clinical trial NCT04375306: Resting Full-cycle Flow Ratio (RFR) Versus Angiography to Guide Revascularization Strategy in Patients Undergoing Coronary Artery By-pass Grafting (CABG)
Official title: Resting Full-cycle Flow Ratio (RFR) Versus Angiography to Guide Revascularization Strategy in Patients Undergoing Coronary Artery By-pass Grafting (CABG): RFR-CABG Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: RFR guided CABG
angiography guided CABG
Graft dysfunction
Lead sponsor: Diagram B.V.
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: International prospective randomized multicenter superiority trial
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Number of participants who deceased, had a Myocardial Infarction (MI), Clinically-Driven Target Vessel Revascularization (CD-TVR), Stroke or Graft Dysfunction at 3 months post CABG
timeFrame: 3 months
Secondary outcomes:
measure: Cut-off value for the RFR that best predicts graft occlusion
timeFrame: Baseline
measure: Number of participants with graft dysfunction at 3 months post CABG
timeFrame: 3 months
measure: Major adverse cardiac or cerebrovascular event (MACCE), a composite of Death, MI, CD-TVR and Stroke at 1 year
timeFrame: 1 year
measure: Major adverse cardiac or cerebrovascular event (MACCE), a composite of Death, MI, CD-TVR and Stroke at 3 years
timeFrame: 3 years
measure: CD-TVR at 3 months post CABG
timeFrame: 1 year
measure: CD-TVR at 1 year post CABG
timeFrame: 1 year
measure: CD-TVR at 3 years post CABG
timeFrame: 3 years
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda ziekenhuis
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge
city: Katowice
country: Poland
facility: Medical University of Silesia
city: Banská Bystrica
country: Slovakia
facility: SUSCCH
Study officials:
References: