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NCT Number: NCT07314138

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven, Leuven, Vlaams Brabant, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multivessel Hybrid Coronary Revascularization

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 arterial bypass grafting (OPCAB)

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Conversion to Sternotomy

    Time frame: Peri-operatively

    Rate of conversion to sternotomy for minimally invasive coronary surgery (MICS) patients.

  2. Conversion to Cardiopulmonary Bypass

    Time frame: Peri-operatively

    Incidence of hemodynamic support with cardiopulmonary bypass during the surgical procedures.

  3. Intensive Care Unit (ICU) Stay

    Time frame: 30 days postoperatively

    Duration of ICU stay following the surgical procedure (in days).

  4. Postoperative Hospital Stay

    Time frame: 30 days postoperatively

    Total length of postoperative hospital stay (in days).

  5. Mechanical Ventilation Time

    Time frame: 30 days postoperatively

    Total ventilation time during the postoperative period (in hours).

  6. Postoperative Blood Loss

    Time frame: 30 days postoperatively

    Total volume of postoperative blood loss (in milliliters) postoperatively.

  7. 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

  8. Phrenic Nerve Injury

    Time frame: 30 days postoperatively

    Incidence of phrenic nerve injury leading to diaphragm paralysis.

  9. 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.

  10. 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

  11. 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

  12. 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).

  13. 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).

  14. 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.

  15. Target Vessel Revascularization (TVR)

    Time frame: 5 year

    Incidence TVR up to 5 years post-procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Ferdi Akca, MD, PhD

CONTACT

[email protected]

+31 40 239 9111

Ismail Cenik, MD

CONTACT

[email protected]

+31 40 239 9111

Sponsors and collaborators

Lead sponsor

Catharina Ziekenhuis Eindhoven

Other

Collaborators

  • Eindhoven University of Technology
  • Universitaire Ziekenhuizen KU Leuven

Registry information

Official study title

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'

Acronym: MICRA-HYBRID

Important dates

Study start
2026
Primary completion
2029
Study completion
2034
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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