Aortic No-Touch vs Partial Aortic Clamping in Off-Pump CABG

NCT07302659 | Recruiting DMC

• 1 other identifier: 2023ZD0504701
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 4

Brief Summary

To explore surgical strategies that reduce perioperative neurologic complications in cardiovascular surgery, with the aim of improving perioperative outcomes and quality of life while reducing the socioeconomic burden. Specifically: This multicenter, randomized controlled clinical trial will evaluate the benefits of a novel aortic no-touch technique in reducing perioperative silent brain infarction(SBI) among patients undergoing surgical treatment for coronary artery disease. The findings are expected to provide a safe and effective myocardial revascularization strategy for individuals at high risk of cerebral ischemia.

Conditions

Coronary Artery Bypass Graft (CABG)

Keywords

coronary artery bypass graft; Silent Brain Infarction

Outcome Measures

Primary Outcomes (2)

• Saphenous vein graft (SVG) occlusion rate

  Assessed by coronary computed tomography angiography (CCTA)

  1 year after surgery

• New-onset clinical stroke and silent brain infarction (SBI)

  Clinical stroke and SBI assessed at 7 ± 3 days postoperatively; SBI assessed by brain magnetic resonance imaging (MRI).

  7 ± 3 days after surgery

Secondary Outcomes (12)

• Incidence of postoperative delirium

  within 5 postoperative days

• Incidence of perioperative neurocognitive disorder (PND)

  within 7 days after surgery

• Perioperative major adverse cardiovascular and cerebrovascular events (MACCE)

  within 30 postoperative days

• MACCE within 3 months after surgery

  Up to 3 months after surgery (3-month follow-up)

• Clinical stroke within 3 months after surgery

  Up to 3 months after surgery (3-month follow-up)

Study Arms (2)

Traditional off-pump coronary artery bypass grafting (Ao-SVG)

ACTIVE COMPARATOR

Off-pump CABG with proximal saphenous vein graft (SVG) anastomoses constructed on the ascending aorta using a partial-occlusion (side-biting) clamp.

Procedure: Conventional off-pump CABG with partial clamping of the ascending aorta (Ao-SVG)

Aortic no-touch coronary artery bypass grafting (RIMA-SVG)

EXPERIMENTAL

Aortic no-touch off-pump CABG in which the saphenous vein graft (SVG) is anastomosed to the right internal mammary artery (RIMA) as a composite graft, avoiding any clamping or manipulation of the ascending aorta.

Procedure: Aortic no-touch coronary artery bypass grafting (RIMA-SVG)

Interventions

Conventional off-pump CABG with partial clamping of the ascending aorta (Ao-SVG) PROCEDURE

Off-pump CABG with proximal saphenous vein graft (SVG) anastomoses constructed on the ascending aorta using a partial-occlusion (side-biting) clamp.

Traditional off-pump coronary artery bypass grafting (Ao-SVG)

Aortic no-touch coronary artery bypass grafting (RIMA-SVG) PROCEDURE

Ascending aortic no-touch CABG with saphenous vein graft (SVG) anastomosed to the right internal mammary artery (RIMA)

Aortic no-touch coronary artery bypass grafting (RIMA-SVG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (4)

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

Related Publications (2)

• Zhao DF, Edelman JJ, Seco M, Bannon PG, Wilson MK, Byrom MJ, Thourani V, Lamy A, Taggart DP, Puskas JD, Vallely MP. Coronary Artery Bypass Grafting With and Without Manipulation of the Ascending Aorta: A Network Meta-Analysis. J Am Coll Cardiol. 2017 Feb 28;69(8):924-936. doi: 10.1016/j.jacc.2016.11.071.

  PMID: 28231944 RESULT

• Tachibana H, Hiraoka A, Saito K, Naito Y, Chikazawa G, Tamura K, Totsugawa T, Yoshitaka H, Sakaguchi T. Incidence and impact of silent brain lesions after coronary artery bypass grafting. J Thorac Cardiovasc Surg. 2021 Feb;161(2):636-644. doi: 10.1016/j.jtcvs.2019.09.162. Epub 2019 Oct 16.

  PMID: 31735394 RESULT

Central Study Contacts

Lianxin Chen

CONTACT

01088322265; chenlianx1@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 24, 2025
• Study Start: March 10, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)