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Total Arterial Revascularization (TAR)

NCT ID: NCT03753048

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

880 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-13

Study Completion Date

2024-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Coronary Artery Disease Coronary Artery Bypass Grafting

Keywords

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Total Arterial Revascularization Y-Graft In-Situ Coronary Artery Bypass Grafting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Y-Graft

The group includes patients who underwent CABG in Y-Graft Configuration.

Group Type ACTIVE_COMPARATOR

Y-Graft

Intervention Type PROCEDURE

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-Situ

The group includes patients who underwent CABG in In-Situ Configuration.

Group Type ACTIVE_COMPARATOR

In-Situ

Intervention Type PROCEDURE

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.

Interventions

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Y-Graft

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.

Intervention Type PROCEDURE

In-Situ

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kemerovo Cardiology Center

OTHER

Sponsor Role collaborator

Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

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Dmitry Sirota

Head of the surgery of aorta and coronary arteries department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dmitry Sirota, MD

Role: PRINCIPAL_INVESTIGATOR

Meshalkin National Medical Research Center

Locations

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Meshalkin National Medical Research Center

Novosibirsk, Novosibirsk Oblast, Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Dmitry A Sirota, MD

Role: CONTACT

Phone: +79132012140

Email: [email protected]

Facility Contacts

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Dmitry A Sirota, MD

Role: primary

Dmitry Khvan

Role: backup

Other Identifiers

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TAR

Identifier Type: -

Identifier Source: org_study_id