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

NCT07172620 | Recruiting

• 1 other identifier: Arota notouch of MICS-CABG
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Bypass Grafting; Off-pump Coronary Artery Bypass; Minimally Invasive Cardiac Surgery; Coronary Arterial Disease (CAD)

Outcome Measures

Primary Outcomes (2)

• Early Postoperative Saphenous Vein Bridge Vessel Patency Rate

  The patients' bridge vessel patency is assessed by angiography within 1-14 days after surgery.

  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.

  1-14 days after surgery

Secondary Outcomes (2)

• Perioperative Safety Indicators

  One year after surgery

• Survival Analysis

  One year after surgery

Study Arms (2)

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.

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.

Procedure: Multi-branch coronary artery bypass grafting with conventional median open heart and off-pump circulation

Interventions

Non-extracorporeal multiple coronary artery bypass graft (CABG) performed under direct visualization through a small incision in the left side of the chest. PROCEDURE

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.

Exposure group (MICS-Notouch group)

Multi-branch coronary artery bypass grafting with conventional median open heart and off-pump circulation PROCEDURE

Control Group (OPCAB Group): Conventional median open multiple coronary artery bypass grafting with extracorporeal circulation.

Control group (OPCAB group)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients to undergo coronary artery bypass grafting due to coronary heart disease.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Study Officials

• Ling Yunpeng, PhD

  Peking University Third Hospital

  STUDY CHAIR

Central Study Contacts

Gong Yichen, PhD

CONTACT

+8618611693463; 18611693463@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: September 15, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 15, 2025

Record last verified: 2024-09

Locations

CN (1)