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

Diagram Research

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Procedure: RFR guided CABG; Procedure: Angio guided CABG

Study type: Interventional

Funder types: Other

Identifiers

NCT04375306

9333

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

500 participants in 2 patient groups

angiography guided CABG

Active Comparator group

Description:

angiography guided CABG

Treatment:

Procedure: Angio guided CABG

RFR guided CABG

Experimental group

Description:

RFR guided CABG

Treatment:

Procedure: RFR guided CABG