Coronary Artery Bypass Graft (CABG)PROTECT-CABGNCT07302659
Aortic No-Touch vs Partial Aortic Clamping in Off-Pump CABG
A study testing Aortic no-touch coronary artery bypass grafting (RIMA-SVG) and Conventional off-pump CABG with partial clamping of the ascending aorta (Ao-SVG) in people with Coronary Artery Bypass Graft (CABG), run by China National Center for Cardiovascular Diseases at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Graft (CABG)
- What is being tested?
- Aortic no-touch coronary artery bypass grafting (RIMA-SVG) and Conventional off-pump CABG with partial clamping of the ascending aorta (Ao-SVG)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 4 sitesChina
- Study dates
- 10 Mar 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Fuwai Hospital Chinese Academy of Medical Sciences
Beijing
Chen, 01088322265, chenlianx1@163.com
- Not yet recruiting
Peking University First Hospita
Beijing
Wang, +86 13522784537, wj0463@sina.cn
- Not yet recruiting
Qingdao Cardiovascular Hospital
Qingdao
Feng, +86 13964265680, fengzunyi@163.com
- Not yet recruiting
Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
Shenzhen
Nie, +86 13701176101, wangsymd@126.com
About this study
Official title: 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.
- Conditions
- Coronary Artery Bypass Graft (CABG)
- Being tested
- Aortic no-touch coronary artery bypass grafting (RIMA-SVG), Conventional off-pump CABG with partial clamping of the ascending aorta (Ao-SVG)
- Keywords
- coronary artery bypass graft, Silent Brain Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic no-touch coronary artery bypass grafting (RIMA-SVG)Procedure or 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 or surgery
Off-pump CABG with proximal saphenous vein graft (SVG) anastomoses constructed on the ascending aorta using a partial-occlusion (side-biting) clamp.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Aortic no-touch coronary artery bypass grafting (RIMA-SVG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saphenous vein graft (SVG) occlusion rate
Assessed by coronary computed tomography angiography (CCTA)
Measured: 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).
Measured: 7 ± 3 days after surgery
Secondary outcomes (12)
Incidence of postoperative delirium
The incidence of delirium evaluated by CAM/CAM-ICU
Measured: within 5 postoperative days
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).
Measured: within 7 days after surgery
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.
Measured: 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.
Measured: Up to 3 months after surgery (3-month follow-up)
Clinical stroke within 3 months after surgery
Measured: Up to 3 months after surgery (3-month follow-up)
Sternal complications within 3 months after surgery
Measured: Up to 3 months after surgery (3-month follow-up)
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).
Measured: 3 months after surgery
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
Measured: 12 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).
Measured: 12 months after surgery
Sternal complications within 12 months after surgery
Measured: Up to 12 months after surgery (12-month follow-up)
Clinical stroke within 12 months after surgery
Measured: 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.
Measured: Up to 12 months after surgery (12-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start10 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass Graft (CABG)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302659
- Sponsor's protocol ID
- 2023ZD0504701
- Acronym
- PROTECT-CABG
- Status last verified
- Apr 2026
- First submitted
- 19 Nov 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28231944Tachibana 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.
PubMed 31735394
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Techniques to Prevent Perioperative Neurologic Complications in Patients Undergoing Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT07302659
- Acronym / sponsor ID
- PROTECT-CABG / 2023ZD0504701
- Conditions
- Coronary Artery Bypass Graft (CABG)
- Keywords
- coronary artery bypass graft, Silent Brain Infarction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional off-pump coronary artery bypass grafting (Ao-SVG) | Active comparator | 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. |
| Aortic no-touch coronary artery bypass grafting (RIMA-SVG) | Experimental | Procedure: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Procedure or surgery | Aortic no-touch coronary artery bypass grafting (RIMA-SVG) |
| 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. | Procedure or surgery | Traditional off-pump coronary artery bypass grafting (Ao-SVG) |
Primary outcome
Saphenous vein graft (SVG) occlusion rate
Time frame: 1 year after surgery
Assessed by coronary computed tomography angiography (CCTA)
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).
12 secondary outcomes
Incidence of postoperative delirium
Time frame: within 5 postoperative days
Incidence of perioperative neurocognitive disorder (PND)
Time frame: within 7 days after surgery
Perioperative major adverse cardiovascular and cerebrovascular events (MACCE)
Time frame: within 30 postoperative days
MACCE within 3 months after surgery
Time frame: Up to 3 months after surgery (3-month follow-up)
Clinical stroke within 3 months after surgery
Time frame: Up to 3 months after surgery (3-month follow-up)
Sternal complications within 3 months after surgery
Time frame: Up to 3 months after surgery (3-month follow-up)
Cognitive dysfunction at 3 months after surgery
Time frame: 3 months after surgery
Angina within 12 months after surgery
Time frame: 12 months after surgery
Cognitive dysfunction at 12 months after surgery
Time frame: 12 months after surgery
Sternal complications within 12 months after surgery
Time frame: Up to 12 months after surgery (12-month follow-up)
Clinical stroke within 12 months after surgery
Time frame: Up to 12 months after surgery (12-month follow-up)
MACCE within 12 months after surgery
Time frame: Up to 12 months after surgery (12-month follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Results publication: PubMed 28231944Zhao 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.
- Results publication: PubMed 31735394Tachibana 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aortic no-touch coronary artery bypass grafting (RIMA-SVG) and Conventional off-pump CABG with partial clamping of the ascending aorta (Ao-SVG) in people with Coronary Artery Bypass Graft (CABG), run by China National Center for Cardiovascular Diseases at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lianxin Chen (01088322265, chenlianx1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saphenous vein graft (SVG) occlusion rate (time frame: 1 year after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07302659, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.