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

NCT ID: NCT06794359

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2026-12-01

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.

Detailed Description

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 gold standard, has been criticized for its high degree of invasiveness.

Based on this precept, interest has emerged in creating a surgical approach that causes less trauma. Surgical access using minimally invasive incisions are gaining space and have shown less postoperative pain, shorter hospital stays, earlier mobilization and functional recovery, in addition to reducing the costs of the procedure.

Cardiac surgery has some challenges that are beyond other specialties. The heart is a vital organ with intrinsic chronotropism that lies inside a rigid rib cage.

Specifically, in coronary artery bypass graft surgery (CABG), the thin caliber of the coronaries and their distribution throughout the cardiac territories creates even a greater challenge. However, new surgical techniques associated with new devices, demonstrated the viability of complete revascularization through a limited access incision.

In an attempt to minimize surgical trauma and the morbidities caused by conventional median sternotomy and the use of On Pump surgery, some alternatives have emerged with promising results.

Among those efforts, we can highlight the beginning of the coronary artery grafting surgery without the use of cardiopulmonary bypass (Off Pump CABG), followed by hybrid revascularization, minimally invasive surgery by lateral thoracotomy under direct vision, partially assisted robot surgery and fully endoscopic surgery with using robots.

Currently, minimally invasive surgery though mini lateral thoracotomy is the most common technique used. Initially it was used only for the treatment of the left anterior descending artery (LAD), but technology advances and surgical improvement allowed complete revascularization under direct vision. Surgery can be performed with or without the aid of cardiopulmonary bypass (CPB), treatment individualization is necessecary for every case.

This is a pilot study to evaluate the safety and feasibility of Minimally Invasive Coronary Artery Bypass surgery in selected patients ,with multi vessel coronary disease.

Conditions

Coronary Arterial Disease (CAD); Coronary Artery Bypass

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Minimally Invasive Coronary Artery Bypass

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.

Group Type: EXPERIMENTAL

Minimally Invasive Coronary Artery Bypass Grafting

Intervention Type: 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.

Conventional Coronary Artery Bypass Grafting

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.

Group Type: ACTIVE_COMPARATOR

Coronary artery bypass surgery

Intervention Type: 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.

Interventions

Minimally Invasive Coronary Artery Bypass Grafting

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.

Intervention Type: PROCEDURE

Coronary artery bypass surgery

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Luís Alberto Oliveira Dallan

Cardiovacular Surgeon, Director of the Coronary Artery Disease Division at the HC Heart Institute - FMUSP, Associated Professor FMUSP, PhDr in health sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luis Roberto Palma Dallan, MD

Role: STUDY_DIRECTOR

INCOR - Heart Institute from the University of Sao Paulo

Luis Alberto Oliveira Dallan, MD PhD

Role: PRINCIPAL_INVESTIGATOR

INCOR - Heart Institute from the University of Sao Paulo

Locations

INCOR - Heart Institute from the University of Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

2021/11947-5

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CAAE 54175921.8.0000.0068

Identifier Type: -

Identifier Source: org_study_id