NCT03753048

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
880

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

December 11, 2018

Status Verified

December 1, 2018

Enrollment Period

5 years

First QC Date

November 21, 2018

Last Update Submit

December 7, 2018

Conditions

Coronary Artery DiseaseCoronary Artery Bypass Grafting

Keywords

Total Arterial RevascularizationY-GraftIn-SituCoronary Artery Bypass Grafting

Outcome Measures

Primary Outcomes (1)

  • Freedom from MACCE

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

    5 years

Secondary Outcomes (3)

  • Graft patency

    5 years

  • Quality of life (SF-36)

    5 years

  • Treadmill stress test

    5 years

Study Arms (2)

Y-Graft

ACTIVE COMPARATOR

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

Procedure: Y-Graft

In-Situ

ACTIVE COMPARATOR

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

Procedure: In-Situ

Interventions

Y-GraftPROCEDURE

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.

Y-Graft
In-SituPROCEDURE

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.

In-Situ

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meshalkin National Medical Research Center

Novosibirsk, Novosibirsk Oblast, 630055, Russia

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Dmitry Sirota, MD

    Meshalkin National Medical Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dmitry A Sirota, MD

CONTACT

+79132012140sirotad@yandex.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the surgery of aorta and coronary arteries department

Study Record Dates

First Submitted

November 21, 2018

First Posted

November 26, 2018

Study Start

March 13, 2018

Primary Completion

March 1, 2023

Study Completion

March 1, 2024

Last Updated

December 11, 2018

Record last verified: 2018-12

Locations

RU(1)