Multivessel Minimally Invasive Coronary Bypass Grafting as HYBRID Revascularization Versus Conventional Off-pump Coronary Artery Bypass Grafting
NCT ID: NCT07314138
Last Updated: 2026-01-02
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
NA
Total Enrollment
250 participants
Study Classification
INTERVENTIONAL
Study Start Date
2026-04-01
Study Completion Date
2034-05-01
Brief Summary
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The MICRA-HYBRID trial is a prospective, multicenter, randomized controlled study comparing multivessel hybrid coronary revascularization (HCR) as minimally invasive arterial bypass grafting to left-sided coronary targets (LAD and LCx) plus PCI of the RCA versus conventional off-pump coronary artery bypass grafting (OPCAB) via median sternotomy in patients with three-vessel coronary artery disease. The primary goal is to evaluate whether multivessel-HCR provides superior 30-day "textbook" clinical outcomes (mortality, MI, stroke, re-exploration for bleeding, and other complications) while improving perioperative recovery and long-term cardiovascular outcomes.
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Detailed Description
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Coronary artery disease remains the leading cause of cardiovascular mortality worldwide. For complex, multivessel disease, surgical revascularization via CABG or OPCAB remains the guideline-recommended standard due to superior long-term outcomes compared with PCI alone. However, traditional sternotomy CABG/OPCAB is associated with significant surgical trauma, prolonged recovery, and elevated perioperative morbidity.
Minimally invasive coronary surgery (MICS) with off-pump arterial grafting through a small thoracotomy has shown favorable short-term recovery and lower morbidity in both single and multivessel disease cases. Traditionally, MICS has been limited to grafting the left anterior descending artery (LAD), with other coronary lesions treated by PCI, known as hybrid coronary revascularization (HCR). While most studies have focused on single-vessel HCR (typically LAD), the potential long-term benefits of including the circumflex (Cx) artery in a multivessel-HCR strategy remain unexplored. Given that three-vessel CAD is the most common indication for CABG, evaluating a multivessel-HCR approach (LAD + Cx via MICS, RCA via PCI) is essential.
The MICRA-HYBRID trial will randomize 250 patients with three-vessel coronary disease eligible for complete revascularization to either multivessel-HCR or conventional total-arterial OPCAB (median sternotomy, anaortic, off-pump). The primary efficacy endpoint is a composite "Textbook Outcome" at 30 days, defined by absence of death, MI, stroke, re-exploration for bleeding, and other major complications. Secondary endpoints include individual components of the Textbook Outcome, perioperative recovery parameters (ICU/hospital length of stay, ventilator time, transfusion requirement), health-related quality of life (EQ-5D), pulmonary recovery metrics, angina class (CCS), and long-term outcomes including MACCE and target-vessel revascularization up to five years.
Minimally invasive coronary surgery (MICS) with off-pump arterial grafting through a small thoracotomy has shown favorable short-term recovery and lower morbidity in both single and multivessel disease cases. Traditionally, MICS has been limited to grafting the left anterior descending artery (LAD), with other coronary lesions treated by PCI, known as hybrid coronary revascularization (HCR). While most studies have focused on single-vessel HCR (typically LAD), the potential long-term benefits of including the circumflex (Cx) artery in a multivessel-HCR strategy remain unexplored. Given that three-vessel CAD is the most common indication for CABG, evaluating a multivessel-HCR approach (LAD + Cx via MICS, RCA via PCI) is essential.
The MICRA-HYBRID trial will randomize 250 patients with three-vessel coronary disease eligible for complete revascularization to either multivessel-HCR or conventional total-arterial OPCAB (median sternotomy, anaortic, off-pump). The primary efficacy endpoint is a composite "Textbook Outcome" at 30 days, defined by absence of death, MI, stroke, re-exploration for bleeding, and other major complications. Secondary endpoints include individual components of the Textbook Outcome, perioperative recovery parameters (ICU/hospital length of stay, ventilator time, transfusion requirement), health-related quality of life (EQ-5D), pulmonary recovery metrics, angina class (CCS), and long-term outcomes including MACCE and target-vessel revascularization up to five years.
Conditions
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Coronary Artery Disease (CAD)
Bypass, Cardiopulmonary
Minimally Invasive Coronary Revascularization Surgery
Off-pump Coronary Artery Bypass
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Dual center, superiority, randomized controlled trial.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Multivessel hybrid coronary revascularization (HCR)
Minimally invasive coronary artery bypass surgery to the left sided coronary vessels combined with percutaneous coronary intervention to the right coronary artery.
Group Type
ACTIVE_COMPARATOR
Multivessel Hybrid Coronary Revascularization
Intervention Type
PROCEDURE
Multivessel-HCR consists of MICS revascularization of the left sided coronary vessels (LAD , Cx) combined with PCI for the RCA during the same admission or within 4 weeks postoperatively. Surgical revascularization is performed through MICS which consists of either robotically or non-robotically assisted thoracoscopic IMA harvesting followed by total arterial off-pump anastomosis of the grafts through a left anterior 3-5 cm mini-thoracotomy. PCI will be performed via radial or femoral access according to local routine and is restricted to the RCA.
Off-pump coronary artery bypass grafting (OPCAB)
Total arterial, anaortic off-pump ccoronary artery bypass grafting through median sternotomy.
Group Type
ACTIVE_COMPARATOR
Off-pump coronary arterial bypass grafting (OPCAB)
Intervention Type
PROCEDURE
OPCAB will be performed as per clinical routine at each center through a median sternotomy. IMA harvesting (pedicled or skeletonised) follows each center's routine. An anaortic, total arterial strategy with a LIMA-LAD graft and complete revascularisation is obliged.
Interventions
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Multivessel Hybrid Coronary Revascularization
Multivessel-HCR consists of MICS revascularization of the left sided coronary vessels (LAD , Cx) combined with PCI for the RCA during the same admission or within 4 weeks postoperatively. Surgical revascularization is performed through MICS which consists of either robotically or non-robotically assisted thoracoscopic IMA harvesting followed by total arterial off-pump anastomosis of the grafts through a left anterior 3-5 cm mini-thoracotomy. PCI will be performed via radial or femoral access according to local routine and is restricted to the RCA.
Intervention Type
PROCEDURE
Off-pump coronary arterial bypass grafting (OPCAB)
OPCAB will be performed as per clinical routine at each center through a median sternotomy. IMA harvesting (pedicled or skeletonised) follows each center's routine. An anaortic, total arterial strategy with a LIMA-LAD graft and complete revascularisation is obliged.
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
* Patients with three-vessel disease (either angiographic stenoses \>70% or a fractional flow reserve value ≤0.80)
* Left main diameter stenosis ≥50% or a left main intravascular ultrasound minimal luminal area of ≤4.5 mm2 or fractional flow reserve value ≤0.80 combined with significant CAD of the right coronary artery
* Left main diameter stenosis ≥50% or a left main intravascular ultrasound minimal luminal area of ≤4.5 mm2 or fractional flow reserve value ≤0.80 combined with significant CAD of the right coronary artery
Exclusion Criteria
A potential participant who meets any of the following criteria will be excluded from participation in this study:
* Age \< 18 or \> 85 years
* Chronic total occlusion of the RCA
* In-stent RCA restenosis
* RCA stenosis with high-risk clinical features requiring urgent PCI or surgical revasculari-zation.
* Reverse hybrid coronary revascularization, defined as PCI-RCA followed by surgical re-vascularization.
* Acute cardiac ischemia necessitating immediate intervention.
* EF \< 30 %
* eGFR \< 30 ml/min
* Indication for concomitant cardiac surgery (e.g. valve or arrhythmia surgery) or non-cardiac surgery
* Previous thoracic or cardiac surgery, mediastinal irradiation, significant trauma to the chest
* Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure) or cancer.
* Hemodynamically significant left subclavian stenosis
* Severe chest wall deformities
* History of pericarditis
* Body mass index \> 40 Kg/m2.
* Age \< 18 or \> 85 years
* Chronic total occlusion of the RCA
* In-stent RCA restenosis
* RCA stenosis with high-risk clinical features requiring urgent PCI or surgical revasculari-zation.
* Reverse hybrid coronary revascularization, defined as PCI-RCA followed by surgical re-vascularization.
* Acute cardiac ischemia necessitating immediate intervention.
* EF \< 30 %
* eGFR \< 30 ml/min
* Indication for concomitant cardiac surgery (e.g. valve or arrhythmia surgery) or non-cardiac surgery
* Previous thoracic or cardiac surgery, mediastinal irradiation, significant trauma to the chest
* Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure) or cancer.
* Hemodynamically significant left subclavian stenosis
* Severe chest wall deformities
* History of pericarditis
* Body mass index \> 40 Kg/m2.
Minimum Eligible Age
18 Years
Maximum Eligible Age
85 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Sponsor Role
collaborator
Eindhoven University of Technology
OTHER
Sponsor Role
collaborator
Catharina Ziekenhuis Eindhoven
OTHER
Sponsor Role
lead
Responsible Party
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Ferdi Akca
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Ferdi Akca, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Catharina Ziekenhuis Eindhoven
Wouter Oosterlinck, Prof. Dr. MD, PhD
Role: STUDY_CHAIR
Universitaire Ziekenhuizen KU Leuven
Pim Tonino, Prof. Dr. MD, PhD
Role: STUDY_CHAIR
Catharina Ziekenhuis Eindhoven
Locations
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University Hospitals Leuven
Leuven, Vlaams Brabant, Belgium
Site Status
Catharina Hospital Eindhoven
Eindhoven, Eindhoven, Netherlands
Site Status
Countries
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Belgium
Netherlands
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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NL-010448
Identifier Type: -
Identifier Source: org_study_id
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NA
Combined Use of a Novel Cardioplegic Formula With MPS ® Using the MiECC in Isolated CABG Versus OPCABG
NCT03609723
COMPLETED
Coronary Bypass Grafting With Minimal Extracorporeal Circulation System Versus Off-pump Coronary Surgery
NCT02118025
COMPLETED
HYbrid CoronAry Revascularization in DiabeticS
NCT02504762
COMPLETED
NA
The Comparative Effectiveness of Hybrid Revascularization (MIDCAB Then PCI) With DES Versus Multivessel DES PCI or CABG
NCT01699048
COMPLETED
NA
A Study to Determine the Effect of Bi-Ventricular Pacing on Cardiac Hemodynamics After Coronary Artery Bypass Graft
NCT00316368
COMPLETED
PHASE1
Miniaturized Extracorporeal Circulation Study
NCT03216720
COMPLETED
NA
Prospective Cohort Study on Minimal Invasive Coronary Surgery
NCT04267835
RECRUITING
Combined Use of a Novel Cardioplegic Formula With Myocardial Protection System (MPS)® Versus Cardioplexol ® in Isolated Coronary Artery Bypass Grafting (CABG) Using MiECC;
NCT03612388
COMPLETED
Sex-related Differences in Outcome After Hybrid Coronary Revascularization
NCT06023355
NOT_YET_RECRUITING
Does MiECC Improve Outcome in Diabetic Patients Undergoing Elective Coronary Bypass Grafting?
NCT02672514
COMPLETED
NA
Efficacy and Safety of One-Stage Hybrid Coronary Revascularization
NCT04811586
UNKNOWN
NA
Impella Supported OPCABG
NCT04339452
ACTIVE_NOT_RECRUITING
Comparison of Minimal Versus Conventional Extracorporeal Circulation in Coronary Surgery
NCT01603589
COMPLETED
NA
Outcome After Coronary Artery Bypass Grafting
NCT02319083
RECRUITING