Multivessel Minimally Invasive Coronary Bypass Grafting as HYBRID Revascularization Versus Conventional Off-pump Coronary Artery Bypass Grafting (MICRA-HYBRID)

December 23, 2025 updated by: Ferdi Akca, Catharina Ziekenhuis Eindhoven

MICRA-HYBRID Trial: A Randomized Controlled Trial of 'Multivessel Minimally Invasive Coronary Bypass Grafting as HYBRID Revascularization Versus Conventional Off-Pump Coronary Artery Bypass Grafting'

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: 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.
Active Comparator: Off-pump coronary artery bypass grafting (OPCAB)
Total arterial, anaortic off-pump ccoronary artery bypass grafting through median sternotomy.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Absence of Adverse Events within 30 Days Postoperatively (Textbook Outcome)
Time Frame: 30 days postoperatively

The primary endpoint is defined as the "Textbook Outcome," which is the composite absence, within 30 days postoperatively, of the following events:

  • Mortality
  • Re-exploration for bleeding
  • Postoperative ischemia (requiring bypass grafting or acute PCI)
  • Postoperative myocardial infarction (type 5 MI according to the fourth universal definition of myocardial infarction)
  • Cardiac tamponade (requiring surgical or percutaneous intervention)
  • Cerebrovascular accident / transient ischemic attack
  • Wound infection requiring antibiotics or intervention
  • New-onset atrial fibrillation requiring medical anti-thrombotic therapy
  • Pneumonia requiring IV or oral antibiotics
  • Placement of additional chest drains
  • Prolonged hospital stay (> 7 days) after surgery
30 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conversion to Sternotomy
Time Frame: Peri-operatively
Rate of conversion to sternotomy for minimally invasive coronary surgery (MICS) patients.
Peri-operatively
Conversion to Cardiopulmonary Bypass
Time Frame: Peri-operatively
Incidence of hemodynamic support with cardiopulmonary bypass during the surgical procedures.
Peri-operatively
Intensive Care Unit (ICU) Stay
Time Frame: 30 days postoperatively
Duration of ICU stay following the surgical procedure (in days).
30 days postoperatively
Postoperative Hospital Stay
Time Frame: 30 days postoperatively
Total length of postoperative hospital stay (in days).
30 days postoperatively
Mechanical Ventilation Time
Time Frame: 30 days postoperatively
Total ventilation time during the postoperative period (in hours).
30 days postoperatively
Postoperative Blood Loss
Time Frame: 30 days postoperatively
Total volume of postoperative blood loss (in milliliters) postoperatively.
30 days postoperatively
Transfusion Requirement
Time Frame: 30 days postoperatively
Need for transfusion of blood products (packed units of thrombocyt, red blood cells and plasma) during the postoperative period
30 days postoperatively
Phrenic Nerve Injury
Time Frame: 30 days postoperatively
Incidence of phrenic nerve injury leading to diaphragm paralysis.
30 days postoperatively
Postoperative Peak Expiratory Flow (PEF)
Time Frame: 30 days postoperatively
PEF measurement at Day 1 and Day 3 postoperatively, and at 4 weeks post-discharge.
30 days postoperatively
Quality of Life Assessment (EQ-5D)
Time Frame: 1 year
Quality of life assessment using the European Quality of Life-5 Dimensions (EQ-5D) questionnaire at baseline (screening), 2 weeks and 4 weeks postoperatively and at 12 months follow-up
1 year
Angina Assessment (CCS Classification)
Time Frame: 1 year
Assessment of angina using the Canadian Cardiovascular Society (CCS) classification at baseline, discharge and every 3 months for up to 1 year
1 year
Short-term Healthcare Costs
Time Frame: 30 days
Healthcare costs associated with hospitalization within 30 days postoperatively (in euros), including expenses for surgical and percutaneous procedures, diagnostic tests, ICU care, nursing days, reinterventions, complications, and post-discharge admissions (e.g., emergency visits, re-admissions, primary care consultations).
30 days
Long-term Healthcare Costs
Time Frame: 1 year
Healthcare costs within 1 year postoperatively (in euros), including expenses for diagnostic tests, reinterventions, emergency visits, re-admissions, primary care consultations, repeat visits, telephone, video, and written consultations, as well as after-hours urgent care (e.g., on-call GP visits).
1 year
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time Frame: 5 years
Incidence of MACCE including mortality, stroke and myocardial infarction up to 5 years post-procedure.
5 years
Target Vessel Revascularization (TVR)
Time Frame: 5 year
Incidence TVR up to 5 years post-procedure.
5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catharina Ziekenhuis Eindhoven

Collaborators

Universitaire Ziekenhuizen KU Leuven
Eindhoven University of Technology

Investigators

  • Principal Investigator: Ferdi Akca, MD, PhD, Catharina Ziekenhuis Eindhoven
  • Study Chair: Wouter Oosterlinck, Prof. Dr. MD, PhD, Universitaire Ziekenhuizen KU Leuven
  • Study Chair: Pim Tonino, Prof. Dr. MD, PhD, Catharina Ziekenhuis Eindhoven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2034

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

December 23, 2025

First Posted (Estimated)

January 2, 2026

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 23, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL-010448

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD could be made available upon request to the Principal Investigator after the study's completion.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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