Minimally Invasive Coronary Artery Bypass Surgery in Patients With Multi Vessel Coronary Disease
NCT06794359 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-05-04
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
Interventions
- 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.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Fundação de Amparo à Pesquisa do Estado de São Paulo
collaborator OTHER_GOV -
University of Sao Paulo General Hospital
lead OTHER
Principal Investigators
-
Luis Roberto Palma Dallan, MD · INCOR - Heart Institute from the University of Sao Paulo
-
Luis Alberto Oliveira Dallan, MD PhD · INCOR - Heart Institute from the University of Sao Paulo
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-01
- Primary Completion
- 2026-07-01
- Completion
- 2026-12-01
Countries
- Brazil
Study Locations
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