Aortic no-touch versus partial aortic clamping for off-pump coronary bypass
Official title: Surgical Techniques to Prevent Perioperative Neurologic Complications in Patients Undergoing Coronary Artery Bypass Grafting
Run by China National Center for Cardiovascular Diseases · NCT07302659 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 380 (estimated) |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 4 sites (Beijing and 3 other locations) |
| Status | Recruiting |
| Started | March 10, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | June 30, 2028 |
| Registry record updated | April 14, 2026 |
| Trial ID | NCT07302659 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: chenlianx1@163.com
- Phone: 01088322265
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Combining advanced MRI and PET imaging for heart disease prognosis
This study is testing a new way of using advanced MRI and PET scans together to see if it can give better information about heart health for people with heart disease and those who are healthy.
-
Conscious Sedation vs General Anesthesia for Pulsed Field Ablation in Paroxysmal Atrial Fibrillation
This trial tests whether local anesthesia with conscious sedation can match general anesthesia for pulsed field ablation in adults with paroxysmal atrial fibrillation.
-
Biomarkers to predict CSA-AKI risk before heart surgery
This study tests new biomarkers to see if they can predict CSA-AKI risk in adults undergoing cardiovascular surgery.
-
Safety and Efficacy of an Extracorporeal Ventricular Assist System for Cardiogenic Shock
This study tests whether an extracorporeal ventricular assist device can safely provide short-term heart support and help patients with cardiogenic shock or trouble weaning from bypass.
-
QFR-Guided Heart Revascularization Quality Registry in CAD
This registry tests whether using quantitative flow ratio (QFR) to guide coronary revascularization decisions across many centers can standardize quality in patients with coronary artery disease.
-
Perioperative GFR Monitoring to Predict CSA-AKI and CA-AKI
This study tests whether perioperative transcutaneous fluorescence GFR measurements can predict CSA-AKI or CA-AKI in adults undergoing cardiovascular procedures or iodine contrast exposure.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.