Minimally Invasive Coronary Artery Bypass Surgery in Patients With Multi Vessel Coronary Disease

NCT06794359 | Enrolling By Invitation DMC

• 2 other identifiers: CAAE 54175921.8.0000.00682021/11947-5
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Arterial Disease (CAD); Coronary Artery Bypass

Keywords

CABG; MICS CABG; CAD

Outcome Measures

Primary Outcomes (1)

• Feasibility and safety of proposed revascularization through minimally invasive approach

  This is a pilot study that wants to evaluate the feasibility of performing complete CABG through minimamlly invasive access, in patients with multi vessel disease (2 or more diseased coronaries), without compromising safety measured by major adverse events (death, myocardial infarction, stroke, or unplanned revascularization)

  Clinical follow-up intra hospitalar, 30-day and 6 months

Secondary Outcomes (14)

• Intraoperative conversion rate

  Intraoperative measure

• Complete revascularization rate

  Intraoperative measure

• Postoperative bleeding volume

  First 48 hours post-surgery

• Surgery duration

  Intraoperative measure

• Length of orotracheal intubation

  From oral intubation until extubation

Study Arms (2)

Minimally Invasive Coronary Artery Bypass

EXPERIMENTAL

Experimental: Minimally Invasive Coronary Artery Bypass will be performed in a through left anterior mini thoracotomy. Complete revascularization must be performed in all previous determined coronary targets.

Procedure: Minimally Invasive Coronary Artery Bypass Grafting

Conventional Coronary Artery Bypass Grafting

ACTIVE COMPARATOR

Conventional Coronary Artery Bypass Grafting will be performed in a classic manner, through total sternotomy. Complete revascularization must be performed in all previous determined coronary targets.

Procedure: Coronary artery bypass surgery

Interventions

Minimally Invasive Coronary Artery Bypass Grafting PROCEDURE

Minimally Invasive Coronary Artery Bypass Grafting will be accomplished by complete revascularization of all previous defined coronary targets through left anterior thoracotomy. On or off pump approach will be determined by the surgeon. For on pump cases, femoral canulation will be performed and aortic cross clamp will be used. Off Pump cases will be performed using Medtronic Octopus and Starfish NS. Intra operative Transit time flow measurement will be performed in all cases.

Minimally Invasive Coronary Artery Bypass

Coronary artery bypass surgery PROCEDURE

Procedure: Conventional Coronary Artery Bypass Grafting will be accomplished by complete revascularization of all previous defined coronary targets through classical total sternotomy. On or off pump approach will be determined by the surgeon. Intra operative Transit time flow measurement will be performed in all cases.

Conventional Coronary Artery Bypass Grafting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Medtronic: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

INCOR - Heart Institute from the University of Sao Paulo

São Paulo, São Paulo, 05403900, Brazil

Location

Related Publications (1)

• Palma Dallan LR, Ferreira Lisboa LA, Oliveira Dallan LA, Asdrubal Vilca Mejia O, Neves Filho AF, Doenst T, Babliak O, Orellana Sampedro GA, Jatene FB. Minimally invasive coronary artery bypass grafting (MINI-CABG): Protocol for a pilot randomized controlled trial comparing minimally invasive versus conventional coronary surgery. PLoS One. 2025 Dec 29;20(12):e0337829. doi: 10.1371/journal.pone.0337829. eCollection 2025.

  PMID: 41460930 RESULT

Related Links

• Related Info

MeSH Terms

Interventions

Coronary Artery Bypass

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Luis Roberto Palma Dallan, MD

  INCOR - Heart Institute from the University of Sao Paulo

  STUDY DIRECTOR

• Luis Alberto Oliveira Dallan, MD PhD

  INCOR - Heart Institute from the University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiovacular Surgeon, Director of the Coronary Artery Disease Division at the HC Heart Institute - FMUSP, Associated Professor FMUSP, PhDr in health sciences

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: January 27, 2025
• Study Start: October 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: This data will be avalilable 6 months after publication.
• Access Criteria: Journal Editor whrere the paper will be accepted for publication. Other researchers who might want to cooperate on future reseaches.

Locations

BR (1)