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Search / Trial NCT06794359

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

Cabg Mics Cabg Cad

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.

Locations

Sao Paulo, Sp, Brazil

Patients applied

0 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