Radial vs Vena No-Touch Assessment (RAVENTA)

April 22, 2026 updated by: Tomsk Cardiology Research Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Danil V. Timofeev
  • Phone Number: +79059937497
  • Email: 3120v@mail.ru

Study Locations

  • Russia
      • Tomsk, Russia, 634012
        • Recruiting
        • Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk, Russia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Radial artery
Radial artery as a conduit for the circumflex artery territory in 55 patients undergoing coronary artery bypass grafting
Procedure: radial artery graft
Circumflex artery territory revascularization using the radial artery graft
Active Comparator: No-touch great saphenous vein
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
Circumflex artery territory revascularization using a no-touch vein graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The ratio of functioning and closed shunts in both groups
Time Frame: during follow-up time - 12 months
during follow-up time - 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) (number of cases)
Time Frame: Early postoperative (up to 2 weeks)/ Remote postoperative (up to 2 months)
Between groups at 30 days and 12 months after surgery.
Early postoperative (up to 2 weeks)/ Remote postoperative (up to 2 months)
Complications (percent)
Time Frame: Early postoperative (up to 2 weeks)
Complication rates between groups
Early postoperative (up to 2 weeks)
Change in angina class (percent)
Time Frame: Through study completion, an average of 1 year
one year after surgical revascularization in the compared groups
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tomsk Cardiology Research Institute

Investigators

  • Principal Investigator: Yuri Y. Veshersky, MD, PhD, Cardiology Research Institute, Tomsk National Research Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 294

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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