Minimally Invasive Coronary Artery Bypass Surgery in Patients With Multi Vessel Coronary Disease
Launched by UNIVERSITY OF SAO PAULO GENERAL HOSPITAL · Jan 20, 2025
Trial Information
Current as of July 23, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
Minimally invasive surgery has been a breakthrough in medicine, especially in more developed countries. It represents an evolution of current techniques associated with new technologic devices, that allow a safe and effective procedure associated to an aesthetic benefit.
Invasive treatment of coronary artery disease has been on a plateau lately. Percutaneous treatment that emerged as a promise to replace surgical methods, has already shown its limitations, even with the use of drug-eluting stents. Traditional CABG (coronary artery bypass grafting surgery), which has been considered the gol...
Gender
ALL
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
About University Of Sao Paulo General Hospital
The University of São Paulo General Hospital (Hospital das Clínicas da Universidade de São Paulo) is a leading clinical research institution in Brazil, renowned for its commitment to advancing medical knowledge and patient care. As an academic hospital affiliated with one of the largest and most prestigious universities in Latin America, it integrates clinical practice, education, and research. The hospital conducts a wide array of clinical trials across various medical disciplines, aiming to develop innovative therapies and improve healthcare outcomes. With a multidisciplinary team of healthcare professionals and access to cutting-edge facilities, the University of São Paulo General Hospital is dedicated to fostering scientific advancements and addressing critical health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sao Paulo, Sp, Brazil
Patients applied
Trial Officials
Luis Roberto Palma Dallan, MD
Study Director
INCOR - Heart Institute from the University of Sao Paulo
Luis Alberto Oliveira Dallan, MD PhD
Principal Investigator
INCOR - Heart Institute from the University of Sao Paulo
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported