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

Coronary Artery Disease Clinical Trial

— RFR-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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04375306
• Other study ID #: 9333
• Status: Recruiting
• Phase: N/A
• Start date: February 3, 2020
• Est. completion date: June 30, 2027

Study information

• Verified date: January 2024
• Source: Diagram B.V.
• Contact: Prof. E. Kedhi, MD, PhD
• Phone: +31 384262999
• Email: ekedhi[@]me.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 30, 2027
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• RFR guided CABG
All patients will undergo RFR and FFR measurement before CABG. RFR and FFR values will be blinded to the patients. In the experimental arm the decision to revascularize will be based on RFR.
• Angio guided CABG
All patients will undergo RFR and FFR measurement before CABG. RFR and FFR values will be blinded to the patients. In the control arm the RFR values will be blinded to the cardiothoracic surgeon.

Locations

Country	Name	City	State
Belgium	Imelda ziekenhuis	Bonheiden
Belgium	AZ Sint-Jan Brugge	Brugge
Poland	Medical University of Silesia	Katowice
Slovakia	SUSCCH	Banská Bystrica

Sponsors (1)

Lead Sponsor	Collaborator
Diagram B.V.

Countries where clinical trial is conducted

Belgium,  Poland,  Slovakia, 

Outcome

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