NCT07172620 Safety and Effectiveness of No-touch Technique for Ascending Aorta in MICS-CABG
| NCT ID | NCT07172620 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University Third Hospital |
| Condition | Coronary Artery Bypass Grafting |
| Study Type | OBSERVATIONAL |
| Enrollment | 260 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 260 participants in total. It began in 2025-06-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Ling Yunpeng, PhD
STUDY CHAIR
Peking University Third Hospital
Frequently Asked Questions
Who can join the NCT07172620 clinical trial?
This trial is open to participants of all sexes, studying Coronary Artery Bypass Grafting. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07172620 currently recruiting?
Yes, NCT07172620 is actively recruiting participants. Contact the research team at 18611693463@126.com for enrollment information.
Where is the NCT07172620 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07172620 clinical trial?
NCT07172620 is sponsored by Peking University Third Hospital. The principal investigator is Ling Yunpeng, PhD at Peking University Third Hospital. The trial plans to enroll 260 participants.