NCT04375306 Resting Full-cycle Flow Ratio (RFR) Versus Angiography to Guide Revascularization Strategy in Patients Undergoing Coronary Artery By-pass Grafting (CABG)
| NCT ID | NCT04375306 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Diagram B.V. |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2020-02-03 |
| Primary Completion | 2024-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2020-02-03 with a primary completion date of 2024-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04375306 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04375306 currently recruiting?
Yes, NCT04375306 is actively recruiting participants. Contact the research team at ekedhi@me.com for enrollment information.
Where is the NCT04375306 trial being conducted?
This trial is being conducted at Bonheiden, Belgium, Bruges, Belgium, Katowice, Poland, Banská Bystrica, Slovakia.
Who is sponsoring the NCT04375306 clinical trial?
NCT04375306 is sponsored by Diagram B.V.. The trial plans to enroll 500 participants.