NCT07552948

Brief Summary

This study examines the outcomes of coronary artery bypass grafting (CABG) in women at 1 year after surgery. A randomized controlled trial is planned, including a comparative analysis of two observed groups depending on the chosen conduit for revascularization of the circumflex artery. The main group is supposed to include 55 patients undergoing CABG with the use of the radial artery, while the control group will include 55 patients undergoing CABG with the use of the great saphenous vein prepared using the no-touch technique.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
35mo left

Started Apr 2026

Typical duration for not_applicable

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 Progress3%
Apr 2026Apr 2029

Study Start

First participant enrolled

April 6, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 27, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

April 13, 2026

Last Update Submit

April 22, 2026

Conditions

Coronary Artery Atherosclerosis

Keywords

Coronary artery atherosclerosisno-touch veinradial artery

Outcome Measures

Primary Outcomes (1)

  • The ratio of functioning and closed shunts in both groups

    during follow-up time - 12 months

Secondary Outcomes (3)

  • Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) (number of cases)

    Early postoperative (up to 2 weeks)/ Remote postoperative (up to 2 months)

  • Complications (percent)

    Early postoperative (up to 2 weeks)

  • Change in angina class (percent)

    Through study completion, an average of 1 year

Study Arms (2)

Radial artery

ACTIVE COMPARATOR

Radial artery as a conduit for the circumflex artery territory in 55 patients undergoing coronary artery bypass grafting

Procedure: radial artery graft

No-touch great saphenous vein

ACTIVE COMPARATOR

No-touch great saphenous vein graft for revascularization of the circumflex artery territory in 55 patients during coronary artery bypass grafting

Procedure: no-touch vein graft

Interventions

radial artery graftPROCEDURE

Circumflex artery territory revascularization using the radial artery graft

Radial artery
no-touch vein graftPROCEDURE

Circumflex artery territory revascularization using a no-touch vein graft

No-touch great saphenous vein

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Three-vessel disease involving the target circumflex artery with stenosis ≥70% and a diameter ≥1.5 mm
  • Females aged 18 years and older
  • Signed informed consent
  • Clinical indications for coronary revascularization (refractory angina/transient myocardial ischemia according to noninvasive tests)

You may not qualify if:

  • Previous cardiac surgery of any type, including CABG
  • Combined procedures
  • Ineligibility for venous or radial artery harvesting as determined by preoperative Doppler flowmetry or clinical examination that would compromise graft patency.
  • Acute myocardial ischemia
  • EF less than 35%
  • CKD 4.5
  • Inability to understand the nature, scope, and consequences of the clinical trial, or to provide written informed consent due to cognitive impairment or mental illness.
  • Life expectancy less than 1 year due to non-cardiac diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk, Russia

Tomsk, 634012, Russia

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Yuri Y. Veshersky, MD, PhD

    Cardiology Research Institute, Tomsk National Research Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vasily V. Zatolokin, PhD

CONTACT

+79138490545zatolokin@cardio-tomsk.ru

Danil V. Timofeev

CONTACT

+790599374973120v@mail.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 27, 2026

Study Start

April 6, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2029

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)