Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT06794359
Eligibility Criteria:
Inclusion Criteria:
* Patients 18-years-old or older
* Isolated myocardial revascularization procedure
* Double or Triple-vessel disease with proximal or mid LAD disease with angiographic diameter stenosis \> 70% by visual analysis in all territories, requiring myocardial revascularization OR proximal LAD disease with angiographic diameter stenosis 50-70% by visual analysis in any territory but with invasive or non-invasive evidence of flow-limiting stenosis in all three territories, requiring myocardial revascularization
* Total SYNTAX score \> 22 or low Syntax score unsuitable for PCI
* Clinical and anatomic eligibility for both Minimally invasive and Conventional CABG surgery as agreed to by surgical team.
* Silent ischemia, stable angina, unstable angina or recent MI
\- If recent MI, cardiac biomarkers must have returned to normal prior to randomization
* Ability to sign informed consent and comply with all study procedures
Exclusion Criteria:
* Reoperation
* Need for any concomitant cardiac surgery other than CABG (e.g. valve surgery, aortic repair, etc.), or intent that if the patient randomizes to surgery, any cardiac surgical procedure other than isolated CABG will be performed
* Left ventricle disfunction (EF\<40%)
* Chronic Pulmonary obstructive disease
* Renal failure disease
* Emergency surgery
* Obesity
* Sternum anatomic defects including pectus excavatum
* Peripheral vascular disease
* Ascending aorta severe calcification
* Non cardiac co-morbidities with life expectancy less than 1 year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06794359
Study Brief:
Protocol Section:
NCT06794359