Total Arterial Revascularization (TAR)

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03753048
• Other study ID #: TAR
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2018
• Est. completion date: March 2024

Study information

• Verified date: December 2018
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Dmitry A Sirota, MD
• Phone: +79132012140
• Email: sirotad[@]yandex.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 880
• Est. completion date: March 2024
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Bypass Grafting
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Russian Federation	Meshalkin National Medical Research Center	Novosibirsk	Novosibirsk Region

Sponsors (2)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation	Kemerovo Cardiology Center

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from MACCE	Composite MACCE (mortality, myocardial infarction, repeated revascularization, stroke)	5 years
Secondary	Graft patency	Graft patency in 5 years	5 years
Secondary	Quality of life (SF-36)	Assessment of the patient's quality of life by the Short Form-36 in 5 years	5 years
Secondary	Treadmill stress test	Non-invasive diagnosis of myocardial ischemia	5 years