Total Arterial Revascularization (TAR)

Not Applicable

• Conditions: Coronary Artery Disease; Coronary Artery Bypass Grafting
• Interventions: Procedure: Y-Graft; Procedure: In-Situ

• Registration Number: NCT03753048
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

Total arterial revascularisation with in-situ confihuration of BITA is superior than y-graft in patients underwent CABG.

Detailed Description

The main hypothesis of the trial is that in-situ configuration of bilateral internal thoracic arteries is superior than Y-graft configuration for MACCE (mortality, myocardial infarction, repeat revascularization, stroke) during mid-term follow-up in patients with CAD who is shedueled for CABG.

Study Timeline

• Study Start: 2018-03-13
• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-26
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-07
• Last Update Posted: 2018-12-11
• Primary Completion: 2023-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 880

Inclusion Criteria

• Coronary Artery Disease
• Stable angina
• The need for revascularization of anterior descending and obtuse margin arteries accoring to the 2018 ESC/EACTS Guidelines on myocardial revascularization
• Informed Consent Form

Exclusion Criteria

• The diameter of the target arteries is less than 1 mm
• Stenosis of the subclavian arteries more than 60%
• STEMI less than 3 month
• Previous cardiac surgery
• BMI >35
• COPD with FEV1 <60%
• Concomitant pathology that requires simultaneous surgical treatment
• Cancer with life expectancy less than 5 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Y-Graft	Y-Graft	The group includes patients who underwent CABG in Y-Graft Configuration.
In-Situ	In-Situ	The group includes patients who underwent CABG in In-Situ Configuration.

Primary Outcome Measures

Name	Time	Method
Freedom from MACCE	5 years	Composite MACCE (mortality, myocardial infarction, repeated revascularization, stroke)

Secondary Outcome Measures

Name	Time	Method
Treadmill stress test	5 years	Non-invasive diagnosis of myocardial ischemia
Graft patency	5 years	Graft patency in 5 years
Quality of life (SF-36)	5 years	Assessment of the patient's quality of life by the Short Form-36 in 5 years

Trial Locations

Locations (1)

Meshalkin National Medical Research Center; 🇷🇺 Novosibirsk, Novosibirsk Region, Russian Federation