Status:
TERMINATED
FUNctional eFficacy of Hybrid coronAry REvascularization
Lead Sponsor:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
The purpose of the study is to compare iFR-guided hybrid coronary revascularization (HCR) and traditional coronary artery bypass grafting (CABG) in terms of a functional efficacy of revascularization ...
Detailed Description
New generation of drug eluting stents (DES) have been shown to have better long-term patency rates than the vein grafts utilized in conventional CABG. Then, it may be expected that hybrid coronary rev...
Eligibility Criteria
Inclusion
- Signed written informed consent
- Stenosis ≥70% of the LAD and/or ≥50% of left main coronary artery in combination with at least one stenosis ≥70% of the Cx or RCA, suitable for revascularization (decided by a heart team)
- SYNTAX value ≥22.
- Clinical indications for coronary revascularization (angina refractory to optimal medical treatment, ischemia on non-invasive tests, reduced left ventricular ejection fraction)
Exclusion
- Previous heart surgery of any kind, including CABG
- Previous surgery involving the left pleural space
- The need for concomitant vascular or other cardiac surgery during index procedure (valve surgery, aortic surgery, left ventricular aneurysmectomy, endarterectomy, etc.)
- Chronic lung disease
- Chronic kidney disease determined as eGFR\<60 ml/min/sq.m
- Failure to give informed consent.
- Life expectancy due to non-heart disease is less than 1 year.
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2023
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04698460
Start Date
January 15 2021
End Date
May 5 2023
Last Update
May 8 2023
Active Locations (1)
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1
Cardiology Research Institute, Tomsk National Research Medical Centre, Russian Academy of Sciences
Tomsk, Tomsk Oblast, Russia, 634012