Actively Recruiting
Resting Full-cycle Flow Ratio (RFR) Versus Angiography to Guide Revascularization Strategy in Patients Undergoing Coronary Artery By-pass Grafting (CABG)
Led by Diagram B.V. · Updated on 2024-02-01
500
Participants Needed
4
Research Sites
386 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Resting Full-cycle Flow Ratio (RFR) Versus Angiography to Guide Revascularization Strategy in Patients Undergoing Coronary Artery By-pass Grafting (CABG)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All patients 18 years or older undergoing coronary artery bypass grafting (CABG)
- Patients willing and able to provide written informed consent
You will not qualify if you...
- Previous coronary artery bypass grafting (CABG)
- Severe valvular disease requiring surgery along with CABG
- Remaining expected coronary stenosis of greater than 50% diameter distally to graft anastomosis
- Left ventricular ejection fraction less than 30%
- Known transmural myocardial infarction
- Documented microvascular disease
- RFR/FFR measurement judged impossible
- Life expectancy less than 2 years
- Participation in other investigational clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Imelda ziekenhuis
Bonheiden, Belgium
Actively Recruiting
2
AZ Sint-Jan Brugge
Bruges, Belgium
Active, Not Recruiting
3
Medical University of Silesia
Katowice, Poland
Actively Recruiting
4
SUSCCH
Banská Bystrica, Slovakia
Actively Recruiting
Research Team
P
Prof. E. Kedhi, MD, PhD
CONTACT
S
S. Postma, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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