Total Arterial Revascularization (TAR)

December 7, 2018 updated by: Dmitry Sirota, Meshalkin Research Institute of Pathology of Circulation

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

880

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
    • Novosibirsk Region
      • Novosibirsk, Novosibirsk Region, Russian Federation, 630055
        • Recruiting
        • Meshalkin National Medical Research Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from MACCE
Time Frame: 5 years
Composite MACCE (mortality, myocardial infarction, repeated revascularization, stroke)
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Collaborators

Kemerovo Cardiology Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2018

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

November 21, 2018

First Submitted That Met QC Criteria

November 21, 2018

First Posted (Actual)

November 26, 2018

Study Record Updates

Last Update Posted (Actual)

December 11, 2018

Last Update Submitted That Met QC Criteria

December 7, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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