Aortic no-touch versus partial aortic clamping for off-pump coronary bypass

Surgical Techniques to Prevent Perioperative Neurologic Complications in Patients Undergoing Coronary Artery Bypass Grafting

This trial will test whether an aortic no-touch technique reduces silent brain infarctions compared with partial aortic clamping in adults having off-pump coronary artery bypass surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 380 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: China National Center for Cardiovascular Diseases (Government)
• Locations: 4 sites (Beijing and 3 other locations)
• Trial ID: NCT07302659 on ClinicalTrials.gov

What this trial studies

This multicenter randomized controlled trial in China compares an aortic no-touch bypass technique (using RIMA-SVG) with conventional off-pump CABG that uses partial ascending aortic clamping (Ao-SVG). Adult patients with multivessel coronary artery disease scheduled for isolated off-pump CABG are randomized to one of the two surgical strategies and monitored for perioperative silent brain infarctions using neuroimaging and neurocognitive testing. Key exclusions include prior cardiac surgery, need for on-pump surgery, unsuitable graft conduits, severe aortic calcification, and contraindications to MRI. The trial aims to identify which revascularization approach better reduces perioperative cerebral ischemia and related morbidity.

Who should consider this trial

Good fit: Adults over 18 with multivessel coronary artery disease scheduled for isolated off-pump CABG who have suitable graft conduits and can undergo MRI and neurocognitive testing are ideal candidates.

Not a fit: Patients who require on-pump CABG, have severe ascending aortic calcification, unsuitable grafts, prior cardiac surgery, or cannot undergo MRI or complete cognitive testing are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the no-touch approach could reduce silent brain infarctions, improve early cognitive outcomes and quality of life after CABG, and lower related healthcare costs.

How similar studies have performed: Prior observational studies and some randomized work suggest aortic no-touch strategies reduce clinically apparent stroke and embolic signals, but randomized evidence specifically targeting silent brain infarction is limited.

Eligibility criteria

Inclusion Criteria:

* Adult patients (\>18 years old) with multivessel coronary artery disease who are scheduled to undergo isolated off-pump coronary artery bypass grafting and who provide informed consent to participate in this study.

Exclusion Criteria:

* Indications for cardiopulmonary bypass surgery (or no contraindications to on-pump surgery);
* Great saphenous vein is unsuitable for use as a graft conduit;
* Subclavian artery stenosis or occlusion, or any contraindication to the use of the internal mammary artery as a graft conduit;
* History of previous cardiac surgery;
* Emergency surgery;
* Inability to apply an aortic clamp due to severe ascending aortic calcification;
* Expected inability to tolerate MRI or contraindications to MRI (e.g., known intolerance to MRI, an implanted permanent pacemaker, or an anticipated need for permanent pacemaker implantation);
* Inability to complete neurocognitive assessment due to language barriers or visual/hearing impairment.

Where this trial is running

Beijing and 3 other locations

• Fuwai Hospital Chinese Academy of Medical Sciences — Beijing, China (Recruiting)
• Peking University First Hospita — Beijing, China (Not_yet_recruiting)
• Qingdao Cardiovascular Hospital — Qingdao, China (Not_yet_recruiting)
• Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen — Shenzhen, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Lianxin Chen

Conditions Coronary Artery Bypass Graft; coronary artery bypass graft; Silent Brain Infarction