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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    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/Surgery

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

Treatment groups

380 Participants
are divided into 2 treatment groups
Group A: Traditional off-pump coronary artery bypass grafting (Ao-SVG)Active comparator 1 intervention
Group B: Aortic no-touch coronary artery bypass grafting (RIMA-SVG)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Saphenous vein graft (SVG) occlusion rate

Assessed by coronary computed tomography angiography (CCTA)

Time frame
1 year after surgery
2

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).

Time frame
7 ± 3 days after surgery

Secondary outcomes

1

Incidence of postoperative delirium

The incidence of delirium evaluated by CAM/CAM-ICU

Time frame
within 5 postoperative days
2

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).

Time frame
within 7 days after surgery
3

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.

Time frame
within 30 postoperative days
4

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.

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

Other outcomes

Sponsors and contacts

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