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

NCT04375306 | Recruiting

• 1 other identifier: 9333
• Study Type: interventional
• Target: 500
• Locations: 3 countries
• Sites: 4

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.

Conditions

Coronary Artery Disease

Keywords

RFR guided CABG; angiography guided CABG; Graft dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• CD-TVR at 3 months post CABG

  1 year

Study Arms (2)

angiography guided CABG

ACTIVE COMPARATOR

angiography guided CABG

Procedure: Angio guided CABG

RFR guided CABG

EXPERIMENTAL

RFR guided CABG

Procedure: RFR guided CABG

Interventions

RFR guided CABG PROCEDURE

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.

RFR guided CABG

Angio guided CABG PROCEDURE

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.

angiography guided CABG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients between 18 or older undergoing CABG
• Patients willing and capable to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Diagram B.V.: lead

Study Sites (4)

Imelda ziekenhuis

Bonheiden, Belgium

RECRUITING

AZ Sint-Jan Brugge

Bruges, Belgium

ACTIVE NOT RECRUITING

Medical University of Silesia

Katowice, Poland

RECRUITING

SUSCCH

Banská Bystrica, Slovakia

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Prof. E. Kedhi, MD, PhD

CONTACT

+31 384262999; ekedhi@me.com

S. Postma, PhD

CONTACT

+31 384262999; rfrcabg.trial@diagram-zwolle.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All patients will undergo RFR and FFR measurement before CABG. RFR and FFR values will be blinded to the patients in both arms. In the control arm (angiography guided CABG) the RFR values will be blinded to the cardiothoracic surgeon.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: International prospective randomized multicenter superiority trial

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 5, 2020
• Study Start: February 3, 2020
• Primary Completion: October 31, 2024
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

BE (2); PL (1); SL (1)