Resting Full-cycle Flow Ratio (RFR) Versus Angiography to Guide Revascularization Strategy in Patients Undergoing Coronary Artery By-pass Grafting (CABG)
NCT ID: NCT04375306
Last Updated: 2024-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2020-02-03
2027-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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angiography guided CABG
angiography guided CABG
Angio guided CABG
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.
RFR guided CABG
RFR guided CABG
RFR guided CABG
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.
Interventions
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RFR guided CABG
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.
Angio guided CABG
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.
Eligibility Criteria
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Inclusion Criteria
* Patients willing and capable to provide written informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Diagram B.V.
OTHER
Responsible Party
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Locations
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Imelda ziekenhuis
Bonheiden, , Belgium
AZ Sint-Jan Brugge
Bruges, , Belgium
Medical University of Silesia
Katowice, , Poland
SUSCCH
Banská Bystrica, , Slovakia
Countries
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Central Contacts
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Facility Contacts
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Dr. Dewilde, MD, PhD
Role: primary
Pawel Gasior, MD
Role: primary
Martin Hudec, MD, PhD
Role: primary
Other Identifiers
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9333
Identifier Type: -
Identifier Source: org_study_id
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