Coronary Arterial Disease (CAD)MINICABGNCT06794359
Minimally Invasive Coronary Artery Bypass Surgery in Patients With Multi Vessel Coronary Disease
A study testing Minimally Invasive Coronary Artery Bypass Grafting and Coronary artery bypass surgery in people with Coronary Arterial Disease (CAD) and Coronary Artery Bypass, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arterial Disease (CAD), Coronary Artery Bypass
- What is being tested?
- Minimally Invasive Coronary Artery Bypass Grafting and Coronary artery bypass surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2023to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
INCOR - Heart Institute from the University of Sao Paulo
São Paulo, São Paulo, 05403900
About this study
Official title: 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
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.
Read the 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.
- Being tested
- Minimally Invasive Coronary Artery Bypass Grafting, Coronary artery bypass surgery
- Keywords
- CABG, MICS CABG, CAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Coronary Artery Bypass GraftingProcedure or surgery
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.
Coronary artery bypass surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Coronary artery bypass surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Clinical follow-up intra hospitalar, 30-day and 6 months
Secondary outcomes (14)
Intraoperative conversion rate
Conversion rate
- Off Pump to On Pump surgery (regardless of mini thoracotomy or conventional sternotomy)
- mini thoracotomy to conventional sternotomy
Measured: Intraoperative measure
Complete revascularization rate
Surgical team will define preoperatively the number of coronaries to be grafted. After the surgical procedure is completed, the number of performed grafts will be compared to the initial plan. Incomplete revascularization will be considered if the number of grafts performed is lower than the predicted. This is important to measure feasibility
Measured: Intraoperative measure
Postoperative bleeding volume
Postoperative bleeding volume will be measured in the first 48 hours after surgery. It will also be correlated to pre and postoperative hematocrit values. Blood flow transfusions during surgery and 24 hours after surgery will be measured.
Measured: First 48 hours post-surgery
Surgery duration
Surgery duration (hours) will be timed from the skin incision until skin dressing is finished.
Measured: Intraoperative measure
Length of orotracheal intubation
Orotracheal intubation will be measured in hours from the oral intubation to extubation
Measured: From oral intubation until extubation
Length of ICU and hospital stay
Length of ICU and hospital stay (days) will be timed from patient's entry on the sector until medical discharge is determined by intensive care and/or cardiology teams.
Measured: From ICU admission to discharge
Intra operative graft evaluation
Intra operative time flow measurement (TTFM) allows measuring the graft flow using the MedStim devices.
Three variables are analyzed: Graft flow, pulsatility index and diastolic flow percentage.
Normal flow measures are expected to be over 15ml/min, pulsatility index is expected to be lower than 5 and diastolic flow percentage is expected to be over 50%.
This is an important and specific assessment carried out exclusively during the surgical procedure.
If the values found in the data differ from the data considered normal (shown above), reevaluation of the graft through exploration of the anastomosis should be considered.
This values will be compared in the group of patients operated through regular sternotomy and those operated through left mini thoracotomy. If statistical differences are found it could suggest that the quality of the anastomosis colud differ between techniques
Measured: This is a specific assessment carried out during the surgical procedure (intraoperative).
Postoperative myocardial infarction
Periprocedural myocardial infarction (type 5 MI) will be defined according to the Fourth Universal Definition of Myocardial Infarction (UDMI-4, 2018) as an elevation of cardiac troponin values greater than 10 times the upper reference limit (URL) in patients with normal baseline levels, accompanied by at least one of the following objective indicators of myocardial ischemia: New pathological Q waves on electrocardiogram; new left bundle branch block; new regional motion abnormalities on echocardiography; angiography evidence of new occlusion of a native coronary artery or bypass graft.
To enhance methodological rigor and allow comparison with contemporary clinical trials, the periprocedural MI definition proposed by the Academic Research Consortium-2 (ARC-2) will also be adopted as a secondary criterion, which includes: Troponin elevation >70× URL, or CK-MB elevation >10× URL, in association with hemodynamic instability, need for circulatory support.
Measured: Within 48 hours following surgery
Surgical Mortality
Operative mortality and is defined as:
- all deaths, regardless of cause, occurring within 30 days from the procedure (including patients transferred to other care facilities);
- all deaths, regardless of cause, occurring after discharge from the hospital, but before the end of the 30th postoperative day (except for traumatic / external causes)
Measured: 30 days postoperatively
Wound infection
Wound infection will be defined by the presence of phlogistic signs at the incision, associated to the presence of purulent secretion and laboratorial exams.
Measured: From the date of surgery through 30 days postoperatively.
Post operatative atrial fibrillation
Postoperative atrial fibrillation (AF) will be defined as any new-onset episode requiring medical treatment, excluding patients with a prior or chronic history atrial fibrillation. Time Frame: AF assessment will be assessed at three time points:
- Immediate postoperative: from the day of surgery to postoperative day 7.
- Early late postoperative: from postoperative day 8 to day 30.
- Late outpatient assessment: between 30 days and 6 months post-surgery.
Measured: Immediate postoperative: from the day of surgery to postoperative day 7. • Early late postoperative: from postoperative day 8 to day 30. • Late outpatient assessment: between 30 days and 6 months post-surgery.
Neurological events
Procedure related stroke will be defined as a new neurological deficit lasting more than 72 hours, confirmed by neurological examination and brain imaging (computed tomography and/or magnetic resonance), with interpretation by a neurologist. Stroke assessment will be performed at threetime points:
- Immediate postoperative: from the day of surgery to postoperative day 7.
- Early late postoperative: from postoperative day 8 to day 30.
- Late outpatient assessment: between 30 days and 6 months post-surgery.
Measured: Stroke related to surgery will be acessed in phases: • Immediate postoperative: from the day of surgery to postoperative day 7. • Early late postoperative: from postoperative day 8 to day 30. • Late outpatient assessment: between 30 days and 6 months po
Quality of Life Assessed by EQ-5D-5L
Postoperative quality of life will be assessed using the EuroQol EQ-5D-5L questionnaire, administered by telephone within 6 months after surgery.
Measured: Within 6 Months After Surgery
Safety Assessed by Incidence of Major Adverse Cardiovascular and Cerebral Events (MACCE) Postoperatively
Left anterior minithoracotomy surgery will be considered safe if the patient's postoperative recovery occurs with similar incidence of of major cardiac or cerebral events, as compared to the classical sternotomy (considered the gold standard procedure).
Safety will be measured by major cariovascular and cerebral events, that include:
- Cause of death (cardiac vs. non-cardiac);
- Myocardial infarction type
- stroke type and severity.
All this variables mentioned are described with details on its respectives outcomes measures
Measured: At 30 days and 6 months following hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start1 Oct 2023
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Luís Alberto Oliveira Dallan, University of Sao Paulo General Hospital
- Investigators
- Luis Roberto Palma Dallan, MD, Study director, INCOR - Heart Institute from the University of Sao PauloLuis Alberto Oliveira Dallan, MD PhD, Principal investigator, INCOR - Heart Institute from the University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794359
- Sponsor's protocol ID
- CAAE 54175921.8.0000.0068
- Other IDs
- 2021/11947-5
- Acronym
- MINICABG
- Status last verified
- Jun 2025
- First submitted
- 14 Oct 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Necessary data will be shared uppon request, preserving patient's identification. (information that underlie results in a publication)
Publications
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.
PubMed 41460930
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06794359
- Acronym / sponsor ID
- MINICABG / CAAE 54175921.8.0000.0068
- Keywords
- CABG, MICS CABG, CAD
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Medtronic, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally Invasive Coronary Artery Bypass | Experimental | Procedure: Minimally Invasive Coronary Artery Bypass GraftingExperimental: 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. |
| Conventional Coronary Artery Bypass Grafting | Active comparator | Procedure: Coronary artery bypass surgeryConventional 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally Invasive Coronary Artery Bypass GraftingMinimally 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 or surgery | Minimally Invasive Coronary Artery Bypass |
| Coronary artery bypass surgeryProcedure: 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. | Procedure or surgery | Conventional Coronary Artery Bypass Grafting |
Primary outcome
Feasibility and safety of proposed revascularization through minimally invasive approach
Time frame: Clinical follow-up intra hospitalar, 30-day and 6 months
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)
14 secondary outcomes
Intraoperative conversion rate
Time frame: Intraoperative measure
Complete revascularization rate
Time frame: Intraoperative measure
Postoperative bleeding volume
Time frame: First 48 hours post-surgery
Surgery duration
Time frame: Intraoperative measure
Length of orotracheal intubation
Time frame: From oral intubation until extubation
Length of ICU and hospital stay
Time frame: From ICU admission to discharge
Intra operative graft evaluation
Time frame: This is a specific assessment carried out during the surgical procedure (intraoperative).
Postoperative myocardial infarction
Time frame: Within 48 hours following surgery
Surgical Mortality
Time frame: 30 days postoperatively
Wound infection
Time frame: From the date of surgery through 30 days postoperatively.
Post operatative atrial fibrillation
Time frame: Immediate postoperative: from the day of surgery to postoperative day 7. • Early late postoperative: from postoperative day 8 to day 30. • Late outpatient assessment: between 30 days and 6 months post-surgery.
Neurological events
Time frame: Stroke related to surgery will be acessed in phases: • Immediate postoperative: from the day of surgery to postoperative day 7. • Early late postoperative: from postoperative day 8 to day 30. • Late outpatient assessment: between 30 days and 6 months po
Quality of Life Assessed by EQ-5D-5L
Time frame: Within 6 Months After Surgery
Safety Assessed by Incidence of Major Adverse Cardiovascular and Cerebral Events (MACCE) Postoperatively
Time frame: At 30 days and 6 months following hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Results publication: PubMed 41460930Palma 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Necessary data will be shared uppon request, preserving patient's identification. (information that underlie results in a publication)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally Invasive Coronary Artery Bypass Grafting and Coronary artery bypass surgery in people with Coronary Arterial Disease (CAD) and Coronary Artery Bypass, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and safety of proposed revascularization through minimally invasive approach (time frame: Clinical follow-up intra hospitalar, 30-day and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06794359, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.