Aortic No-Touch vs Partial Aortic Clamping in Off-Pump CABG (PROTECT-CABG)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Bypass Graft (CABG)
• Intervention / Treatment: Procedure: Aortic no-touch coronary artery bypass grafting (RIMA-SVG); Procedure: Conventional off-pump CABG with partial clamping of the ascending aorta (Ao-SVG)

• Study Type: Interventional
• Enrollment (Estimated): 380
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lianxin Chen; Phone Number: 01088322265; Email: chenlianx1@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Fuwai Hospital Chinese Academy of Medical Sciences
    • Contact: Chen; Phone Number: 01088322265; Email: chenlianx1@163.com
  • Beijing, China
    • Not yet recruiting
    • Peking University First Hospita
    • Contact: Wang; Phone Number: +86 13522784537; Email: wj0463@sina.cn
  • Qingdao, China
    • Not yet recruiting
    • Qingdao Cardiovascular Hospital
    • Contact: Feng; Phone Number: +86 13964265680; Email: fengzunyi@163.com
  • Shenzhen, China
    • Not yet recruiting
    • Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
    • Contact: Nie; Phone Number: +86 13701176101; Email: wangsymd@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional off-pump coronary artery bypass grafting (Ao-SVG); 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); Off-pump CABG with proximal saphenous vein graft (SVG) anastomoses constructed on the ascending aorta using a partial-occlusion (side-biting) clamp.
Experimental: Aortic no-touch coronary artery bypass grafting (RIMA-SVG); 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); Ascending aortic no-touch CABG with saphenous vein graft (SVG) anastomosed to the right internal mammary artery (RIMA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative delirium	The incidence of delirium evaluated by CAM/CAM-ICU	within 5 postoperative days
Perioperative major adverse cardiovascular and cerebrovascular events (MACCE)	Major adverse cardiovascular and cerebrovascular events are defined as the composite of all-cause death, myocardial infarction, stroke and repeat revascularization.	within 30 postoperative days
MACCE within 3 months after surgery	Major adverse cardiovascular and cerebrovascular events are defined as the composite of all-cause death, myocardial infarction, stroke and repeat revascularization.	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)
Sternal complications within 3 months after surgery		Up to 3 months after surgery (3-month follow-up)
Angina within 12 months after surgery	Patients will complete the Seattle Angina Questionnaire (SAQ) at baseline pre-procedure and again at 12 months post CABG	12 months after surgery
Sternal complications within 12 months after surgery		Up to 12 months after surgery (12-month follow-up)
Clinical stroke within 12 months after surgery		Up to 12 months after surgery (12-month follow-up)
MACCE within 12 months after surgery	Major adverse cardiovascular and cerebrovascular events are defined as the composite of all-cause death, myocardial infarction, stroke and repeat revascularization.	Up to 12 months after surgery (12-month follow-up)
Incidence of perioperative neurocognitive disorder (PND)	Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). Montreal Cognitive Assessment (MoCA; range 0-30 points, higher scores indicate better cognitive function).	within 7 days after surgery
Cognitive dysfunction at 3 months after surgery	Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). Montreal Cognitive Assessment (MoCA; range 0-30 points, higher scores indicate better cognitive function).	3 months after surgery
Cognitive dysfunction at 12 months after surgery	Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). Montreal Cognitive Assessment (MoCA; range 0-30 points, higher scores indicate better cognitive function).	12 months after surgery

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: coronary artery bypass graft; Silent Brain Infarction
• Other Study ID Numbers: 2023ZD0504701

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