Minimally Invasive Coronary Artery Bypass Surgery in Patients With Multi Vessel Coronary Disease (NCT06794359) | Clinical Trial Compass
By InvitationNot Applicable
Minimally Invasive Coronary Artery Bypass Surgery in Patients With Multi Vessel Coronary Disease
Brazil100 participantsStarted 2023-10-01
Plain-language summary
The objective of this study is to evaluate the safety and feasibility of Minimally Invasive Coronary Artery Bypass surgery in selected patients ,with multi vessel coronary disease.
This trial is designed to be a pilot study that will gather comparative information on the clinical performance of the minimally invasive treatment, evaluated by the composite measure of all-cause death, myocardial infarction, stroke, or unplanned repeat revascularization - in hospital, 30-day and 6 months.
Who can participate
Age range18 Years
SexALL
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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…
What they're measuring
1
Feasibility and safety of proposed revascularization through minimally invasive approach
Timeframe: Clinical follow-up intra hospitalar, 30-day and 6 months