Total Arterial Revascularization (TAR)

Sponsor

Meshalkin Research Institute of Pathology of Circulation (Other)

Overall Status

Recruiting

CT.gov ID

NCT03753048

Collaborator

Kemerovo Cardiology Center (Other)

880

Enrollment

Location

Arms

71.6

Anticipated Duration (Months)

12.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Coronary Artery Bypass Grafting	Procedure: Y-Graft Procedure: In-Situ	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

880 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Comparison of Total Arterial Revascularization of Y-Graft Versus In-Situ Configuration Using Bilateral Internal Thoracic Arteries

Actual Study Start Date :

Mar 13, 2018

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Y-Graft The group includes patients who underwent CABG in Y-Graft Configuration.	Procedure: 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.
Active Comparator: In-Situ The group includes patients who underwent CABG in In-Situ Configuration.	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.

Arm

Intervention/Treatment

Active Comparator: Y-Graft

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

Procedure: 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.

Active Comparator: In-Situ

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

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.

Outcome Measures

Primary Outcome Measures

Freedom from MACCE [5 years]
Composite MACCE (mortality, myocardial infarction, repeated revascularization, stroke)

Secondary Outcome Measures

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
Treadmill stress test [5 years]
Non-invasive diagnosis of myocardial ischemia

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Meshalkin National Medical Research Center	Novosibirsk	Novosibirsk Region	Russian Federation	630055

Sponsors and Collaborators

Meshalkin Research Institute of Pathology of Circulation
Kemerovo Cardiology Center

Investigators

Principal Investigator: Dmitry Sirota, MD, Meshalkin National Medical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dmitry Sirota, Head of the surgery of aorta and coronary arteries department, Meshalkin Research Institute of Pathology of Circulation

ClinicalTrials.gov Identifier:

NCT03753048

Other Study ID Numbers:

First Posted:

Nov 26, 2018

Last Update Posted:

Dec 11, 2018

Last Verified:

Dec 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dmitry Sirota, Head of the surgery of aorta and coronary arteries department, Meshalkin Research Institute of Pathology of Circulation

Total Arterial Revascularization

Y-Graft

In-Situ

Coronary Artery Bypass Grafting

Additional relevant MeSH terms:

Coronary Artery Disease

Study Results

No Results Posted as of Dec 11, 2018