NCT06794359

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

Minimally Invasive Coronary Artery Bypass Surgery: Prospective and Randomized Study to Validate the Minimally Invasive Approach Through Left Anterior Mini Thoracotomy in Patients With Milti Vessel Coronary Disease

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.
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.

Timeline

• Start date: 2023-10-01
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2025-01-27
• Last updated: 2025-06-08

Locations

1 site across 1 country: Brazil