Radial vs Vena No-Touch Assessment
ConditionCoronary Artery Atherosclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorTomsk Cardiology Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
radial artery graft
Procedure/SurgeryCircumflex artery territory revascularization using the radial artery graft
no-touch vein graft
Procedure/SurgeryCircumflex artery territory revascularization using a no-touch vein graft
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Radial arteryActive comparator 1 intervention
Group B: No-touch great saphenous veinActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The ratio of functioning and closed shunts in both groups
Time frame
during follow-up time - 12 monthsSecondary outcomes
1
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) (number of cases)
Between groups at 30 days and 12 months after surgery.
Time frame
Early postoperative (up to 2 weeks)/ Remote postoperative (up to 2 months)2
Complications (percent)
Complication rates between groups
Time frame
Early postoperative (up to 2 weeks)3
Change in angina class (percent)
one year after surgical revascularization in the compared groups
Time frame
Through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov