Resting Full-cycle Flow Ratio (RFR) Versus Angiography to Guide Revascularization Strategy in Patients Undergoing Coronary Artery By-pass Grafting (CABG): RFR-CABG Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Diagram B.V.
- Enrollment
- 500
- Locations
- 4
- Primary Endpoint
- 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
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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
Time Frame: 3 months
Secondary Outcomes
- 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)