Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04375306

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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