FUNctional eFficacy of Hybrid coronAry REvascularization

NCT04698460 | Terminated DMC

• 1 other identifier: 005/e-4
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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 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

Coronary Artery Disease

Keywords

Myocardial Revascularization; Coronary Artery Bypass; Internal Mammary-Coronary Artery Anastomosis; Drug-Eluting Stents

Outcome Measures

Primary Outcomes (1)

• Functional efficacy of revascularization

  Will be assessed as weighted average of the residual (12 month post-procedure) iFRs in coronary arteries that had at least one significant stenosis (\>70% for CABG group, iFR ≤ 0.89 for iFR-guided HCR) and diameter ≥1.5 mm at baseline. In case of proximal lesions of LAD, Cx, RCA, the coefficients 0.5; 0.25; 0.25 will be used, respectively. For other lesions Duke jeopardy scores will be used instead (for this scoring, the coronary tree is divided into 6 segments:1) LAD beyond the diagonal branch take-off, 2) major diagonal branch of the LAD, 3) major septal branch of the LAD, 4) Cx beyond the major obtuse margin branch take-off, 5) major obtuse margin branch, and 6) the posterior descending branch of the RCA. Each such segment is assigned 2 points with a possible maximum of 12/12.

  From baseline to 12 month

Secondary Outcomes (17)

• Between-group difference in the number of major cardiovascular and cerebral events (MACCE)

  From baseline to 12 months, 3, and 5 years

• Between-group difference in the functional efficacy of the revascularization of non-LAD arteries

  From baseline to 12 months

• Between-group difference in the functional completeness of the revascularization

  From baseline to 12 months

• Between-group difference in the number of serious adverse events (other than MACCE)

  From baseline to 12 months

• Between-group difference in the frequency of serious adverse events in the peri-operative period

  From the day of procedure to one week post-procedure

Study Arms (2)

Hybrid coronary revascularization (HCR)

EXPERIMENTAL

Patients with multi-vessel CAD randomized to hybrid coronary revascularization

Procedure: Hybrid coronary revascularization

Conventional coronary artery bypass grafting (CABG)

ACTIVE COMPARATOR

Patients with multi-vessel CAD randomized to conventional CABG

Procedure: Coronary artery bypass grafting

Interventions

Hybrid coronary revascularization PROCEDURE

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

Hybrid coronary revascularization (HCR)

Coronary artery bypass grafting PROCEDURE

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

Conventional coronary artery bypass grafting (CABG)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Cardiology Research Institute, Tomsk National Research Medical Centre, Russian Academy of Sciences

Tomsk, Tomsk Oblast, 634012, Russia

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Stanislav Pekarskiy

  Cardiology Research Institute, TNRMC

  PRINCIPAL INVESTIGATOR

• Yuri Vecherskiy

  Cardiology Research Institute, TNRMC

  PRINCIPAL INVESTIGATOR

• Boris Kozlov

  Cardiology Research Institute, TNRMC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead researcher

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: January 7, 2021
• Study Start: January 15, 2021
• Primary Completion: May 5, 2023
• Study Completion: May 5, 2023
• Last Updated: May 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)