Total Arterial Revascularization (TAR)

Meshalkin Research Institute of Pathology of Circulation880 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

880

Conditions

Coronary Artery Disease Coronary Artery Bypass Grafting

Interventions

Y-GraftPROCEDURE

Y-Graft Configuration Using BITA. Surgery can be performed off-pump or on the CPB. Both internal thoracic arteries should be harvested in semi-sceletonized fashion. After the administration of 3 mg/kg i/v UFH, the left internal thoracic artery is cut off distally and the right internal thoracic artery is cut off proximally and distally. Then they anastomose the following way. Left internal thoracic artery should be anastomosed to the left anterior descending artery (LAD) at first. Secondly, distal part of the right internal thoracic artery should be anastomosed to the obtuse marginal artery. Finally, proximal part of the right internal thoracic artery is anastomosed to the left internal thoracic artery as Y-graft in the end to side fashion. If it is nessesary, the right coronary artery system can be bypassed by separate autoarterial (eg. radial artery) or autovenous graft with proximal anastomose to the aorta.

In-SituPROCEDURE

In-Situ Configuration Using BITA. Surgery can be performed off-pump or on the CPB. Both internal thoracic arteries should be harvested in semi-sceletonized fashion. After the administration of 3 mg/kg i/v UFH, both internal thoracic arteries are cut off distally. Then they anastomose the following way. Right internal thoracic artery should be anastomosed to the left anterior descending artery (LAD) at first. Secondly, left internal thoracic artery should be anastomosed to the obtuse marginal artery. If it is nessesary, the right coronary artery system can be bypassed by separate autoarterial (eg. radial artery) or autovenous graft with proximal anastomose to the aorta.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Meshalkin National Medical Research Center

Novosibirsk, Novosibirsk Oblast, Russia

RECRUITING

Outcomes

Primary Outcomes

Freedom from MACCE

Composite MACCE (mortality, myocardial infarction, repeated revascularization, stroke)

Time frame: 5 years

Secondary Outcomes

Graft patency

Graft patency in 5 years

Time frame: 5 years

Quality of life (SF-36)

Assessment of the patient's quality of life by the Short Form-36 in 5 years

Time frame: 5 years

Treadmill stress test

Non-invasive diagnosis of myocardial ischemia

Time frame: 5 years

Central Contacts

Dmitry A Sirota, MD

CONTACT

+79132012140 sirotad@yandex.ru

Data from ClinicalTrials.gov

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