Coronary Artery Bypass GraftingNCT07172620
Safety and Effectiveness of No-touch Technique for Ascending Aorta in MICS-CABG
An observational study of Coronary Artery Bypass Grafting and Off-pump Coronary Artery Bypass, run by Peking University Third Hospital at 1 site in China.
Trial summary
The goal of this single-center prospective cohort study is to compare perioperative safety metrics and follow-up survival analyses in patients receiving Minimally Invasive Cardiac Surgery Coronary Artery Bypass Grafting(MICS-CABG) and Off-Pump Coronary Artery Bypass(OPCAB). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Bypass Grafting, Off-pump Coronary Artery Bypass, Minimally Invasive Cardiac Surgery
- What is being tested?
- Non-extracorporeal multiple coronary artery bypass graft (CABG) performed under direct visualization through a small incision in the left side of the chest. and Multi-branch coronary artery bypass grafting with conventional median open heart and off-pump circulation
- Type of treatment
- Surgery or procedure
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients to undergo coronary artery bypass grafting due to coronary heart disease.
Who may be able to join
- Patients with angina pectoris who experience functional limitations in daily life and work despite conservative medical treatment and who require coronary artery bypass grafting surgery, as confirmed by coronary angiography, are eligible for enrollment.
- Patients with calcification of the ascending aorta, as confirmed by CT, who are not suitable for sidewall clamping are also eligible for enrollment.
Who cannot join
- The patient presents with an old, large myocardial infarction with no surviving myocardium, as evidenced by both isotope and echocardiographic imaging. This is a group of patients who are prone to complications, including significant cardiac enlargement, a cardiothoracic ratio greater than 0.75, an ejection fraction (EF) less than 30%, a left ventricular diameter (LVDd) greater than 70mm, the presence of a left ventricular ventricular wall tumor, or severe arrhythmia. Intraoperative hemodynamic instability;
- Valve surgery or other intracardiac surgery at the same time;
- Patients expected to undergo extracorporeal circulation surgery;
- Poor myocardial infarction conditions, extensive lesions, distal or full diffuse stenosis, or lumen diameter less than or severe calcification that cannot be anastomosed.
- Previous open heart surgery.
- Patients with preoperative hemodynamic instability requiring emergency surgery.
- Other conditions include terminal malignant tumors, uncontrollable infections, bleeding, persistent progressive degenerative systemic diseases, severe brain injuries, and multiple organ failure. Additionally, other significant organ function serious impairments, such as severe liver function impairment, severe heart failure, or cardiogenic shock, may also be considered contraindications. Inability to tolerate surgery may also be considered a contraindication.
- The participant declines to take part in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: Safety and Effectiveness of No-touch Technique for Ascending Aorta in Minimally Invasive Cardiac Surgery Coronary Artery Bypass Grafting(MICS-CABG)
The goal of this single-center prospective cohort study is to compare perioperative safety metrics and follow-up survival analyses in patients receiving Minimally Invasive Cardiac Surgery Coronary Artery Bypass Grafting(MICS-CABG) and Off-Pump Coronary Artery Bypass(OPCAB). The main question it aims to answer is:
Is the bridge vessel patency rate of patients in the MICS-Notouch group noninferior to that of a saphenous vein bridge with conventional open-chest bypass?
Read more
Participants will be divided into two groups:
Exposure group (MICS-Notouch group): non-extracorporeal circulation multiple coronary artery bypass grafting surgery performed under direct visualization of a small incision in the left chest, including the application of LIMA (left internal mammary artery) + SVG (saphenous vein) multiple bypass grafting.
Control group (OPCAB group): conventional median chest opening, non-extracorporeal circulation multi-branch coronary artery bypass graft surgery.
Read the detailed description
STATUS OF THE STUDY: Coronary Artery Bypass Grafting (CABG) surgery and Percutaneous Coronary Intervention (PCI) are important methods to address myocardial ischemia in coronary artery disease. CABG surgery, with its internal mammary artery bridging, can achieve a patency rate of more than 90% at 5 years after the procedure, which is currently the gold standard for the treatment of coronary artery disease. Although with the development of drug-eluting stents, coronary spinning mill technology and FFR technology, the incidence of mid- and long-term major adverse cardiovascular and cerebrovascular events (MACCE) of PCI treatment has been greatly reduced, CABG surgery is still the first choice for patients with complex coronary artery disease, left main stem disease and diabetes mellitus and other high-risk patients. However, traditional CABG surgery requires splitting the sternum, which is highly traumatic compared with PCI treatment, and carries a high surgical risk for patients with advanced age and comorbidities, as well as the risk of non-healing of the sternum. Minimal Invasive Cardiac Surgery-Coronary Artery Bypass Grafting surgery (MICS-CABG surgery) can reduce surgical trauma, surgical blood transfusion, and shorten postoperative hospitalization due to the avoidance of sternum injury.
Due to space constraints, MICS-CABG surgery cannot apply a proximal anastomosis to the ascending aorta and requires the use of a special sidewall clamp to clamp the ascending aorta, which poses two potential risks: 1. In patients with calcification and thickening of the ascending aorta, clamping of the ascending aorta may cause rupture of the intimal plaque and dislodgement, which can lead to the risk of cerebral infarction and peripheral arterial embolism; 2. minimal incision In bypass surgery, the proximal anastomosis of the ascending aorta has a very low tolerance rate. Due to the deep location of the ascending aorta, the surgical field and operating space are limited, and the suture is extremely difficult, if the anastomosis process occurs in the case of vascular tear, anastomotic leakage, or dislodgement of the sidewall clamp, it will cause serious uncontrollable aortic bleeding, which may endanger the patient's life in a short period of time.
SIGNIFICANCE: The optimization of the MICS-CABG surgical protocol through this topic reduces the surgical risk and removes the obstacles for the promotion of this technology.
In order to solve the problem of proximal anastomosis of MICS-CABG surgery in patients with calcification of the ascending aorta and to reduce the difficulty and risk of surgery. In 2020, our center began to explore the minimally invasive bypass surgery of ascending aorta non-touch (No-touch) technology, which refers to the bypass surgery without any manipulation of the ascending aorta, the proximal anastomosis of the bridge vessel in the axillary artery, through the first intercostal space of the bridge vessel to the thoracic cavity for the distal continuation of the anastomosis. The advantages of this technique are: 1) avoiding ascending aortic manipulation eliminates the risk of cerebral infarction and peripheral arterial embolism caused by plaque dislodgement from the ascending aorta; 2) the axillary artery rarely exists in calcification, and the vascular condition is good; 3) the axillary artery is simple to reveal, with plenty of room for maneuvering, and it can be anastomosed under direct vision, which greatly reduces the difficulty of the procedure, and if the anastomosis bleeds after the completion of the anastomosis, the bleeding is simple to stop, which decreases the risk of surgical manipulation.
This study will evaluate the safety and efficacy of this technique in a prospective cohort study. If the safety and efficacy of this technique are confirmed to be good, it will greatly expand the indications of this cutting-edge technique of MICS-CABG, optimize the surgical plan, reduce the surgical difficulty and shorten the learning curve.
- Conditions
- Coronary Artery Bypass Grafting, Off-pump Coronary Artery Bypass, Minimally Invasive Cardiac Surgery, Coronary Arterial Disease (CAD)
- Being tested
- Non-extracorporeal multiple coronary artery bypass graft (CABG) performed under direct visualization through a small incision in the left side of the chest., Multi-branch coronary artery bypass grafting with conventional median open heart and off-pump circulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-extracorporeal multiple coronary artery bypass graft (CABG) performed under direct visualization through a small incision in the left side of the chest.Procedure or surgery
Exposure group (MICS-Notouch group): Direct visualization non-extracorporeal coronary artery bypass grafting with a small left chest incision, including the use of LIMA (left internal mammary artery) + SVG (saphenous vein) multibranch bypass grafting.
Multi-branch coronary artery bypass grafting with conventional median open heart and off-pump circulationProcedure or surgery
Control Group (OPCAB Group): Conventional median open multiple coronary artery bypass grafting with extracorporeal circulation.
| Study group | Role | What they receive |
|---|---|---|
| Exposure group (MICS-Notouch group) | Patients enrolled underwent non-extracorporeal coronary artery bypass grafting under direct vision through a small left thoracotomy, including the use of LIMA (left internal mammary artery) + SVG (saphenous vein graft) multibranch bypass grafts. Receives: Procedure: Non-extracorporeal multiple coronary artery bypass graft (CABG) performed under direct visualization through a small incision in the left side of the chest. | |
| Control group (OPCAB group) | Patients enrolled underwent conventional median open-heart surgery with multiple coronary artery bypass grafting under off-pump circulation. Receives: Procedure: Multi-branch coronary artery bypass grafting with conventional median open heart and off-pump circulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Postoperative Saphenous Vein Bridge Vessel Patency Rate
The patients' bridge vessel patency is assessed by angiography within 1-14 days after surgery.
Measured: 1-14 days after surgery
Early Postoperative Saphenous Vein Bridge Vessel Patency Rate
The patients' bridge vessel patency is assessed by Coronary Computed Tomography Angiography within 1-14 days after surgery.
Measured: 1-14 days after surgery
Secondary outcomes (2)
Perioperative Safety Indicators
The following variables were considered: transfusion volume, extracorporeal circulation transfer rate, IABP and ECMO utilization rate, reoperation rate, incidence of poor wound healing, 1-year postoperative bridging vessel patency rate (CT or angiography), incidence of perioperative MACCE, incidence of atrial fibrillation, incidence of renal failure, incidence of re-tracheal intubation, duration of postoperative hospitalization, duration of ICU stay, duration of mechanical ventilation, and hospitalization costs.
Measured: One year after surgery
Survival Analysis
The occurrence of MACCE (including all-cause mortality, re-bypass or stenting, acute infarction, and stroke), as well as readmission for infarction or heart failure at 1, 3, 6, and 12 months postoperatively, will be monitored.
Measured: One year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass GraftingStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 260 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ling Yunpeng, PhD, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172620
- Sponsor's protocol ID
- Arota notouch of MICS-CABG
- Status last verified
- Sep 2024
- First submitted
- 7 Apr 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of No-touch Technique for Ascending Aorta in Minimally Invasive Cardiac Surgery Coronary Artery Bypass Grafting(MICS-CABG)
- ClinicalTrials.gov ID
- NCT07172620
- Acronym / sponsor ID
- Arota notouch of MICS-CABG
- Conditions
- Coronary Artery Bypass Grafting, Off-pump Coronary Artery Bypass, Minimally Invasive Cardiac Surgery, Coronary Arterial Disease (CAD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 15 Sep 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.
The goal of this single-center prospective cohort study is to compare perioperative safety metrics and follow-up survival analyses in patients receiving Minimally Invasive Cardiac Surgery Coronary Artery Bypass Grafting(MICS-CABG) and Off-Pump Coronary Artery Bypass(OPCAB). The main question it aims to answer is:
Is the bridge vessel patency rate of patients in the MICS-Notouch group noninferior to that of a saphenous vein bridge with conventional open-chest bypass?
Participants will be divided into two groups:
Exposure group (MICS-Notouch group): non-extracorporeal circulation multiple coronary artery bypass grafting surgery performed under direct visualization of a small incision in the left chest, including the application of LIMA (left internal mammary artery) + SVG (saphenous vein) multiple bypass grafting.
Control group (OPCAB group): conventional median chest opening, non-extracorporeal circulation multi-branch coronary artery bypass graft surgery.
Detailed description
STATUS OF THE STUDY: Coronary Artery Bypass Grafting (CABG) surgery and Percutaneous Coronary Intervention (PCI) are important methods to address myocardial ischemia in coronary artery disease. CABG surgery, with its internal mammary artery bridging, can achieve a patency rate of more than 90% at 5 years after the procedure, which is currently the gold standard for the treatment of coronary artery disease. Although with the development of drug-eluting stents, coronary spinning mill technology and FFR technology, the incidence of mid- and long-term major adverse cardiovascular and cerebrovascular events (MACCE) of PCI treatment has been greatly reduced, CABG surgery is still the first choice for patients with complex coronary artery disease, left main stem disease and diabetes mellitus and other high-risk patients. However, traditional CABG surgery requires splitting the sternum, which is highly traumatic compared with PCI treatment, and carries a high surgical risk for patients with advanced age and comorbidities, as well as the risk of non-healing of the sternum. Minimal Invasive Cardiac Surgery-Coronary Artery Bypass Grafting surgery (MICS-CABG surgery) can reduce surgical trauma, surgical blood transfusion, and shorten postoperative hospitalization due to the avoidance of sternum injury.
Due to space constraints, MICS-CABG surgery cannot apply a proximal anastomosis to the ascending aorta and requires the use of a special sidewall clamp to clamp the ascending aorta, which poses two potential risks: 1. In patients with calcification and thickening of the ascending aorta, clamping of the ascending aorta may cause rupture of the intimal plaque and dislodgement, which can lead to the risk of cerebral infarction and peripheral arterial embolism; 2. minimal incision In bypass surgery, the proximal anastomosis of the ascending aorta has a very low tolerance rate. Due to the deep location of the ascending aorta, the surgical field and operating space are limited, and the suture is extremely difficult, if the anastomosis process occurs in the case of vascular tear, anastomotic leakage, or dislodgement of the sidewall clamp, it will cause serious uncontrollable aortic bleeding, which may endanger the patient's life in a short period of time.
SIGNIFICANCE: The optimization of the MICS-CABG surgical protocol through this topic reduces the surgical risk and removes the obstacles for the promotion of this technology.
In order to solve the problem of proximal anastomosis of MICS-CABG surgery in patients with calcification of the ascending aorta and to reduce the difficulty and risk of surgery. In 2020, our center began to explore the minimally invasive bypass surgery of ascending aorta non-touch (No-touch) technology, which refers to the bypass surgery without any manipulation of the ascending aorta, the proximal anastomosis of the bridge vessel in the axillary artery, through the first intercostal space of the bridge vessel to the thoracic cavity for the distal continuation of the anastomosis. The advantages of this technique are: 1) avoiding ascending aortic manipulation eliminates the risk of cerebral infarction and peripheral arterial embolism caused by plaque dislodgement from the ascending aorta; 2) the axillary artery rarely exists in calcification, and the vascular condition is good; 3) the axillary artery is simple to reveal, with plenty of room for maneuvering, and it can be anastomosed under direct vision, which greatly reduces the difficulty of the procedure, and if the anastomosis bleeds after the completion of the anastomosis, the bleeding is simple to stop, which decreases the risk of surgical manipulation.
This study will evaluate the safety and efficacy of this technique in a prospective cohort study. If the safety and efficacy of this technique are confirmed to be good, it will greatly expand the indications of this cutting-edge technique of MICS-CABG, optimize the surgical plan, reduce the surgical difficulty and shorten the learning curve.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure group (MICS-Notouch group) | – | Procedure: Non-extracorporeal multiple coronary artery bypass graft (CABG) performed under direct visualization through a small incision in the left side of the chest.Patients enrolled underwent non-extracorporeal coronary artery bypass grafting under direct vision through a small left thoracotomy, including the use of LIMA (left internal mammary artery) + SVG (saphenous vein graft) multibranch bypass grafts. |
| Control group (OPCAB group) | – | Procedure: Multi-branch coronary artery bypass grafting with conventional median open heart and off-pump circulationPatients enrolled underwent conventional median open-heart surgery with multiple coronary artery bypass grafting under off-pump circulation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients to undergo coronary artery bypass grafting due to coronary heart disease.
Key inclusion criteria (2 listed)
- Patients with angina pectoris who experience functional limitations in daily life and work despite conservative medical treatment and who require coronary artery bypass grafting surgery, as confirmed by coronary angiography, are eligible for enrollment.
- Patients with calcification of the ascending aorta, as confirmed by CT, who are not suitable for sidewall clamping are also eligible for enrollment.
Key exclusion criteria (8 listed)
- The patient presents with an old, large myocardial infarction with no surviving myocardium, as evidenced by both isotope and echocardiographic imaging. This is a group of patients who are prone to complications, including significant cardiac enlargement, a cardiothoracic ratio greater than 0.75, an ejection fraction (EF) less than 30%, a left ventricular diameter (LVDd) greater than 70mm, the presence of a left ventricular ventricular wall tumor, or severe arrhythmia. Intraoperative hemodynamic instability;
- Valve surgery or other intracardiac surgery at the same time;
- Patients expected to undergo extracorporeal circulation surgery;
- Poor myocardial infarction conditions, extensive lesions, distal or full diffuse stenosis, or lumen diameter less than or severe calcification that cannot be anastomosed.
- Previous open heart 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 |
|---|---|---|
| Non-extracorporeal multiple coronary artery bypass graft (CABG) performed under direct visualization through a small incision in the left side of the chest.Exposure group (MICS-Notouch group): Direct visualization non-extracorporeal coronary artery bypass grafting with a small left chest incision, including the use of LIMA (left internal mammary artery) + SVG (saphenous vein) multibranch bypass grafting. | Procedure or surgery | Exposure group (MICS-Notouch group) |
| Multi-branch coronary artery bypass grafting with conventional median open heart and off-pump circulationControl Group (OPCAB Group): Conventional median open multiple coronary artery bypass grafting with extracorporeal circulation. | Procedure or surgery | Control group (OPCAB group) |
Primary outcome
Early Postoperative Saphenous Vein Bridge Vessel Patency Rate
Time frame: 1-14 days after surgery
The patients' bridge vessel patency is assessed by angiography within 1-14 days after surgery.
Early Postoperative Saphenous Vein Bridge Vessel Patency Rate
Time frame: 1-14 days after surgery
The patients' bridge vessel patency is assessed by Coronary Computed Tomography Angiography within 1-14 days after surgery.
2 secondary outcomes
Perioperative Safety Indicators
Time frame: One year after surgery
Survival Analysis
Time frame: One year after surgery
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 15 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Coronary Artery Bypass Graft (CABG)
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.
Ling Yunpeng, PhD study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Bypass Grafting and Off-pump Coronary Artery Bypass, run by Peking University Third Hospital at 1 site 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 2 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 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Gong Yichen, PhD (+8618611693463, 18611693463@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Postoperative Saphenous Vein Bridge Vessel Patency Rate (time frame: 1-14 days 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?
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 15 Sep 2025.