Radial vs Vena No-Touch Assessment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: radial artery graft, no-touch vein graft.
- Who it may be relevant to
- Registry conditions: Coronary Artery Atherosclerosis. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Comparative Study of the Effectiveness of Radial Artery and No-touch Vein in Coronary Artery Bypass Grafting in Women
Overview
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.
Detailed description
The Raventa trial is a prospective, unblinded, randomized single centre trial comprising 110 subjects. Women with left main and/or multivessel disease will be randomized to radial artery (RA) or no-touch vein (NV) grafts to the left coronary system in a 1:1 fashion. The primary outcome will be the ratio of functioning and closed radial artery and no-touch vein bypass grafts in the groups one year after surgery. The secondary outcomes will be:
1. Difference in the composite rate of major adverse cardiac and cerebrovascular events (MACCE) between the groups at 30 days and 12 months after the procedure. For the purposes of this study, MACCE components include all-cause mortality, stroke, myocardial infarction and/or repeat revascularization. 2. Difference in the incidence of complications (hemorrhagic, neurological, infectious, arrhythmological) between the groups. 3. Difference in angina class between the groups at one year after the procedure.
In all patients, 1 internal thoracic artery will be anastomosed to the left anterior descending coronary artery. For patients randomized to the NV group, saphenous no-touch vein grafts will be used for all non-left anterior descending target vessels. For patients randomized to the RA group, the main target vessel of the lateral wall will be grafted with radial artery. Additional grafts can be saphenous veins or supplemental arterial conduits at the surgeon's discretion.
Screening. The screening period will last from the patient's admission to the hospital until the day before surgery. Eligibility for this study will be determined based on the results of routine clinical and instrumental examinations, conducted in accordance with existing clinical practice standards and the Cardiology Research Institute's protocols for this patient category, including coronary angiography, ultrasound, and general clinical tests.
Follow-up period: 12 months after surgery. During this period, information on the disease course and intervention outcomes will be collected. Data on secondary endpoints 1 and 2 will be collected within 30 days postoperatively. A follow-up assessment of the study participants' vital status will be performed in 12 months after surgery, identifying MACCE (all-cause mortality, repeat revascularization, stroke, and myocardial infarction) as well as examining coronary bypasses to assess the primary endpoint and secondary endpoints 1 and 3.
Interventions
- Procedure radial artery graft
Circumflex artery territory revascularization using the radial artery graft - Procedure no-touch vein graft
Circumflex artery territory revascularization using a no-touch vein graft
Primary outcome measures
- The ratio of functioning and closed shunts in both groups [Time frame: during follow-up time - 12 months]
Secondary outcome measures (3)
- Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) (number of cases) [Time frame: Early postoperative (up to 2 weeks)/ Remote postoperative (up to 2 months)]
- Complications (percent) [Time frame: Early postoperative (up to 2 weeks)]
- Change in angina class (percent) [Time frame: Through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Russia · 1 center
- Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of — Tomsk
Identifiers
NCT: NCT07552948 · 294