Radial artery versus no-touch saphenous vein grafts for women having coronary bypass

A Comparative Study of the Effectiveness of Radial Artery and No-touch Vein in Coronary Artery Bypass Grafting in Women

This trial will test whether using the radial artery or a no-touch saphenous vein leads to better one-year graft patency and fewer heart problems in women undergoing coronary bypass surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Tomsk Cardiology Research Institute (Academic / other)
• Locations: 1 site (Tomsk)
• Trial ID: NCT07552948 on ClinicalTrials.gov

What this trial studies

This is a prospective, unblinded, randomized single-center trial enrolling 110 women with left main and/or multivessel coronary disease who require CABG. Participants are randomized 1:1 to receive either a radial artery graft to the lateral wall or no-touch saphenous vein grafts for non-LAD targets, with the internal thoracic artery used to graft the LAD in all patients. The primary outcome is the proportion of functioning versus occluded radial and no-touch vein grafts at one year; secondary outcomes include MACCE at 30 days and 12 months, perioperative complications, and angina class at one year. Additional grafts may be saphenous veins or other arterial conduits at the surgeon's discretion.

Who should consider this trial

Good fit: Women aged 18 or older with three-vessel or left-main coronary disease requiring revascularization and a circumflex target vessel ≥1.5 mm who can give informed consent are ideal candidates.

Not a fit: Patients with prior cardiac surgery, acute myocardial ischemia, left ventricular ejection fraction under 35%, severe chronic kidney disease, inability to tolerate vessel harvesting, or life expectancy under one year are unlikely to benefit or to be eligible.

Why it matters

Potential benefit: If successful, the results could identify which conduit technique keeps grafts open longer and reduces cardiac events for women after CABG.

How similar studies have performed: Previous studies suggest radial arteries tend to have better patency than conventional veins and the no-touch vein technique improves vein graft outcomes, but direct randomized comparisons specifically in women remain limited.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Previous cardiac surgery of any type, including CABG
2. Combined procedures
3. Ineligibility for venous or radial artery harvesting as determined by preoperative Doppler flowmetry or clinical examination that would compromise graft patency.
4. Acute myocardial ischemia
5. EF less than 35%
6. CKD 4.5
7. 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.
8. Life expectancy less than 1 year due to non-cardiac diseases.

Where this trial is running

Tomsk

• Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk, Russia — Tomsk, Russia (Recruiting)

Study contacts

• Principal investigator: Yuri Y. Veshersky, MD, PhD — Cardiology Research Institute, Tomsk National Research Medical Center
• Study coordinator: Vasily V. Zatolokin, PhD

Conditions Coronary Artery Atherosclerosis; Coronary artery atherosclerosis; no-touch vein; radial artery