Safety and Effectiveness of No-touch Technique for Ascending Aorta in MICS-CABG

NCT07172620 · tracked via the Priya Life Science China tracker

Sponsor

Peking University Third Hospital

Phase

Observational

Started

2025-06-01

Last updated

2025-09-15

Condition(s) studied

Coronary Artery Bypass GraftingOff-pump Coronary Artery BypassMinimally Invasive Cardiac SurgeryCoronary Arterial Disease (CAD)

Investigational drug(s) / intervention(s)

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

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.

Multi-branch coronary artery bypass grafting with conventional median open heart and off-pump circulation: Control Group (OPCAB Group): Conventional median open multiple coronary artery bypass grafting with extracorporeal circulation.

Study 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

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Early Postoperative Saphenous Vein Bridge Vessel Patency Rate — 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 — 1-14 days after surgery
The patients' bridge vessel patency is assessed by Coronary Computed Tomography Angiography within 1-14 days after surgery.

Trial sites (1)

Facility	City	Region	Status
Peking University Third Hospital	Beijing	Beijing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07172620 on ClinicalTrials.gov ↗ ← All trials in China