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NCT Number: NCT07302659

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

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.

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Key information

Conditions

Coronary Artery Bypass Graft (CABG)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai Hospital Chinese Academy of Medical Sciences, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

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.

Primary outcomes

  1. Saphenous vein graft (SVG) occlusion rate

    Time frame: 1 year after surgery

    Assessed by coronary computed tomography angiography (CCTA)

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

    Time frame: 7 ± 3 days after surgery

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

Secondary outcomes

  1. Incidence of postoperative delirium

    Time frame: within 5 postoperative days

    The incidence of delirium evaluated by CAM/CAM-ICU

  2. Incidence of perioperative neurocognitive disorder (PND)

    Time frame: within 7 days 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. Perioperative major adverse cardiovascular and cerebrovascular events (MACCE)

    Time frame: within 30 postoperative days

    Major adverse cardiovascular and cerebrovascular events are defined as the composite of all-cause death, myocardial infarction, stroke and repeat revascularization.

  4. MACCE within 3 months after surgery

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

    Major adverse cardiovascular and cerebrovascular events are defined as the composite of all-cause death, myocardial infarction, stroke and repeat revascularization.

  5. Clinical stroke within 3 months after surgery

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

  6. Sternal complications within 3 months after surgery

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

  7. Cognitive dysfunction at 3 months after surgery

    Time frame: 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).

  8. Angina within 12 months after surgery

    Time frame: 12 months after surgery

    Patients will complete the Seattle Angina Questionnaire (SAQ) at baseline pre-procedure and again at 12 months post CABG

  9. Cognitive dysfunction at 12 months after surgery

    Time frame: 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).

  10. Sternal complications within 12 months after surgery

    Time frame: Up to 12 months after surgery (12-month follow-up)

  11. Clinical stroke within 12 months after surgery

    Time frame: Up to 12 months after surgery (12-month follow-up)

  12. MACCE within 12 months after surgery

    Time frame: Up to 12 months after surgery (12-month follow-up)

    Major adverse cardiovascular and cerebrovascular events are defined as the composite of all-cause death, myocardial infarction, stroke and repeat revascularization.

Study contacts

Contact information is provided by the study sponsor or research team.

Lianxin Chen

CONTACT

[email protected]

01088322265

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

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

Acronym: PROTECT-CABG

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Dec 24, 2025
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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