No-touch ascending aorta approach during minimally invasive coronary bypass
Safety and Effectiveness of No-touch Technique for Ascending Aorta in Minimally Invasive Cardiac Surgery Coronary Artery Bypass Grafting(MICS-CABG)
This tests whether a 'no-touch' way of handling the ascending aorta during minimally invasive coronary bypass keeps bypass grafts open as well as conventional off-pump bypass for people who need coronary artery bypass surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 260 (estimated) |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07172620 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults who require multi-vessel coronary artery bypass grafting confirmed by angiography, including some patients with ascending aortic calcification who cannot tolerate sidewall clamping.
Not a fit: Patients with extensive prior myocardial damage, very low ejection fraction, severe ventricular enlargement, unstable intraoperative hemodynamics, or those requiring valve or other intracardiac procedures are unlikely to benefit or qualify.
Why it matters
Potential benefit: If successful, the no-touch MICS approach could provide comparable long-term graft patency with less surgical trauma and faster recovery than conventional off-pump CABG.
How similar studies have performed: Other off-pump and 'no-touch' aortic strategies have shown reduced aortic manipulation and lower stroke risk in non-randomized and some randomized work, but robust randomized data specifically on MICS no-touch graft patency remain limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Gong Yichen, PhD
- Email: 18611693463@126.com
- Phone: +8618611693463
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.