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Total Arterial Revascularization (TAR)

Primary Purpose

Coronary Artery Disease, Coronary Artery Bypass Grafting

Status

Recruiting

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

Y-Graft

In-Situ

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Total Arterial Revascularization, Y-Graft, In-Situ, Coronary Artery Bypass Grafting

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Meshalkin National Medical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Y-Graft

In-Situ

Arm Description

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

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

Outcomes

Primary Outcome Measures

Freedom from MACCE

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

Secondary Outcome Measures

Graft patency

Graft patency in 5 years

Quality of life (SF-36)

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

Treadmill stress test

Non-invasive diagnosis of myocardial ischemia

Full Information

NCT ID

NCT03753048

First Posted

November 21, 2018

Last Updated

December 7, 2018

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Collaborators

Kemerovo Cardiology Center

1. Study Identification

Unique Protocol Identification Number

NCT03753048

Brief Title

Total Arterial Revascularization (TAR)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Recruiting

Study Start Date

March 13, 2018 (Actual)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Meshalkin Research Institute of Pathology of Circulation

Collaborators

Kemerovo Cardiology Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease, Coronary Artery Bypass Grafting

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

880 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Y-Graft

Arm Type

Active Comparator

Arm Description

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

Arm Title

In-Situ

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Y-Graft

Intervention Description

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

Intervention Name(s)

In-Situ

Intervention Description

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.

Primary Outcome Measure Information:

Title

Freedom from MACCE

Description

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

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Graft patency

Description

Graft patency in 5 years

Time Frame

5 years

Title

Quality of life (SF-36)

Description

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

Time Frame

5 years

Title

Treadmill stress test

Description

Non-invasive diagnosis of myocardial ischemia

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dmitry A Sirota, MD

Phone

+79132012140

sirotad@yandex.ru

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dmitry Sirota, MD

Organizational Affiliation

Meshalkin National Medical Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Meshalkin National Medical Research Center

City

Novosibirsk

State/Province

Novosibirsk Region

ZIP/Postal Code

630055

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dmitry A Sirota, MD

Phone

+79132012140

sirotad@yandex.ru

First Name & Middle Initial & Last Name & Degree

Dmitry Khvan

Phone

+79069090505

dmhvan@mail.ru

12. IPD Sharing Statement

Learn more about this trial

Total Arterial Revascularization (TAR)

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