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

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Angio guided CABG; Procedure: RFR guided CABG

• Registration Number: NCT04375306
• Lead Sponsor: Diagram B.V.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-03
• Study First Submitted: 2020-05-01
• Study First Submitted QC: 2020-05-01
• Study First Posted: 2020-05-05
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01
• Primary Completion: 2024-10-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
angiography guided CABG	Angio guided CABG	angiography guided CABG
RFR guided CABG	RFR guided CABG	RFR guided CABG

Primary Outcome Measures

Name	Time	Method
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	3 months

Secondary Outcome Measures

Name	Time	Method
CD-TVR at 3 months post CABG	1 year
CD-TVR at 3 years post CABG	3 years
CD-TVR at 1 year post CABG	1 year
Cut-off value for the RFR that best predicts graft occlusion	Baseline
Number of participants with graft dysfunction at 3 months post CABG	3 months
Major adverse cardiac or cerebrovascular event (MACCE), a composite of Death, MI, CD-TVR and Stroke at 1 year	1 year
Major adverse cardiac or cerebrovascular event (MACCE), a composite of Death, MI, CD-TVR and Stroke at 3 years	3 years

Trial Locations

Locations (4)

AZ Sint-Jan Brugge; 🇧🇪 Brugge, Belgium

SUSCCH; 🇸🇰 Banská Bystrica, Slovakia

Imelda ziekenhuis; 🇧🇪 Bonheiden, Belgium

Medical University of Silesia; 🇵🇱 Katowice, Poland