No-touch ascending aorta approach during minimally invasive coronary bypass

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center prospective cohort compares perioperative safety and longer-term graft patency in patients receiving minimally invasive cardiac surgery coronary artery bypass grafting (MICS-CABG) using a 'no-touch' technique on the ascending aorta versus conventional median sternotomy off-pump CABG (OPCAB). Participants are assigned to an exposure group (MICS-NoTouch with LIMA+SVG via a small left-chest incision and avoidance of proximal ascending aorta anastomosis) or a control group (conventional median sternotomy OPCAB with saphenous vein graft proximal anastomosis to the aorta). Primary analyses test noninferiority of bridge vessel patency rates and compare perioperative safety metrics and survival/MACCE during follow-up. The study enrolls patients indicated for CABG by coronary angiography and may include those with ascending aortic calcification who are unsuitable for sidewall clamping, while excluding patients with very large prior infarcts, severe ventricular dysfunction, or need for concurrent valve surgery.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University Third Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Gong Yichen, PhD
• Email: 18611693463@126.com
• Phone: +8618611693463

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.