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NCT04375306Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 1 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
500 (estimated)
First submitted
1 May 2020
Start date
3 Feb 2020
Primary completion date
31 Oct 2024
Lead sponsor
Diagram B.V.
NCT number
NCT04375306

What you commit to

  • Study type: Interventional
  • Planned participants: 500
  • From 3 Feb 2020 to the primary completion date, 31 Oct 2024
  • 4 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous CABG
  • Concomitant severe valvular disease intervention

Other illness

  • Known transmural myocardial infarction
  • Documented microvascular disease

Lab values

  • Left ventricular ejection fraction \<30%

Age

  • Life expectancy \<2 years

Other

  • Remaining (expected) coronary stenosis of \> 50% diameter stenosis distally to graft anastomosis
  • RFR/FFR measurement judged impossible
  • Participation in other investigational clinical trials

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Imelda Ziekenhuis
Coordinator of this site? Confirm its status
BonheidenBelgiumRecruiting
Az Sint Jan Brugge
Coordinator of this site? Confirm its status
BrugesBelgiumActive, not recruiting
Medical University of Silesia
Coordinator of this site? Confirm its status
KatowicePolandRecruiting
SÚSCCH
Coordinator of this site? Confirm its status
Banská BystricaSlovakiaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.