MedTrace Logo

FUNctional eFficacy of Hybrid coronAry REvascularization

NCT04698460 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2023-05-08

No results posted yet for this study

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 assessed by weighted average of iFRs measured 12 month post-procedure in the qualified coronary arteries (all arteries with at least one significant lesion and diameter \>1.5 mm at baseline). The true significance of coronary artery disease (CAD) is reflected by the pressure gradients in coronary arteries showing the actual drop in myocardial perfusion whereas the degree of anatomical narrowing in fact only indicates a potential for hemodynamical changes that also depend on vessel compliance, distal vascular resistance, and collateral circulation. Then, the true effect of myocardial revascularization as treatment of CAD should be likewise assessed by measuring residual pressure gradients in coronary arteries remaining after revascularization, i.e. as the functional efficacy in analogy to the functional significance of CAD.

Conditions

Interventions

PROCEDURE

Hybrid coronary revascularization

A staged procedure with a minimally invasive direct coronary artery bypass grafting of left anterior descending artery by left internal mammary artery (LIMA-LAD MIDCAB) at first stage, and percutaneous stenting of iFR-significant lesions in non-LAD arteries at the second stage

PROCEDURE

Coronary artery bypass grafting

A conventional procedure of median thoracotomy with on-pump bypass grafting of left anterior descending artery by left internal mammary artery and saphenous vein grafting of circumflex and/or right coronary artery

Sponsors & Collaborators

  • Tomsk National Research Medical Center of the Russian Academy of Sciences

    lead OTHER

Principal Investigators

  • Stanislav Pekarskiy · Cardiology Research Institute, TNRMC

  • Yuri Vecherskiy · Cardiology Research Institute, TNRMC

  • Boris Kozlov · Cardiology Research Institute, TNRMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2023-05-05
Completion
2023-05-05

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04698460 on ClinicalTrials.gov