NCT05757947

Brief Summary

Authors hypothesize that "no-touch" saphenous vein as I graft is superior over conventional "no-touch" saphenous vein as free graft in the incidence of graft patency.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
recruiting

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

December 22, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2025

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

2.3 years

First QC Date

February 24, 2023

Last Update Submit

February 6, 2024

Conditions

Coronary Artery DiseaseCoronary Artery StenosisGraft FailureCardiac IschemiaSurgery

Keywords

no-touch saphenous vein graft; CABG

Outcome Measures

Primary Outcomes (1)

  • Patency of "no-touch" saphenous vein graft

    Assessment of the patency of coronary shunts

    12 months after surgery

Secondary Outcomes (4)

  • Recurrence of angina pectoris

    6 and 12 months after after surgery

  • MACE

    6 and 12 months after after surgery

  • Complications of the conduit fence site

    6 and 12 months after after surgery

  • Survival rate

    6 and 12 months after after surgery

Study Arms (2)

"no-touch" saphenous vein as I-graft

ACTIVE COMPARATOR

Coronary bypass surgery according to the I-graft method. Proximal anastomosis to RIMA.

Procedure: Сoronary bypass surgery according to the I-graft method

"no-touch" saphenous vein as conventional free graft

ACTIVE COMPARATOR

Coronary artery bypass grafting using the free conduit technique. Proximal anastomosis to aorta.

Procedure: Сoronary bypass surgery by the method of free conduit

Interventions

Сoronary bypass surgery according to the I-graft methodPROCEDURE

Revascularization of the right coronary artery basin will be performed using "no-touch" SVG and the formation of an anastomosis of the stump of the right internal mammary artery and end-to-end saphenous vein graft.

"no-touch" saphenous vein as I-graft
Сoronary bypass surgery by the method of free conduitPROCEDURE

Revascularization of the right coronary artery basin will be performed using "no-touch" SVG and anastomosis of the saphenous vein graft to aorta.

"no-touch" saphenous vein as conventional free graft

Eligibility Criteria

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

You may qualify if:

  • Patients with coronary artery disease requiring three-vessel myocardial revascularization
  • Patient consent to the study

You may not qualify if:

  • The diameter of the target arteries for conduits of the internal mammary arteries is less than 1 mm
  • Hemodynamically significant atherosclerosis of the subclavian arteries in the first segment
  • Stenosis of the right coronary artery less than 90%
  • Concomitant pathology requiring additional simultaneous surgical correction
  • Lack of IMA
  • COPD with FEV1 \<60%
  • BMI \>35
  • Prior heart surgery
  • Oncological diseases with a life expectancy of less than 5 years
  • ACS
  • CKD stage 4 and higher
  • The diameter of the SVG is less than 2 mm or its varicose expansion is more than 6 mm
  • CLTI IIb and more
  • Atherosclerosis of the brachiocephalic artery more than 50%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NMCR named after academician E.N. Meshalkin of the Ministry of Health of rhe Russian

Novosibirsk, Novosibirsk Oblast, 630055, Russia

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary Stenosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Dmitry Khvan, Ph.D.

    NMCR named after academician E.N. Meshalkin of the Ministry of Health of rhe Russian

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dmitry Khvan, Ph.D.

CONTACT

+79069090505dmhvan@mail.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
candidate of medical sciences, senior researcher, сardiovascular surgeon of the NMRC named after academician E.N. Meshalkin of the Ministry of Health of Russian Federation

Study Record Dates

First Submitted

February 24, 2023

First Posted

March 7, 2023

Study Start

December 22, 2022

Primary Completion

April 1, 2025

Study Completion

December 22, 2025

Last Updated

February 8, 2024

Record last verified: 2024-02

Locations

RU(1)