An interventional study of Multivessel Hybrid Coronary Revascularization and Off-pump coronary arterial bypass grafting (OPCAB) in Coronary Artery Disease (CAD), Bypass, Cardiopulmonary and Minimally Invasive Coronary Revascularization Surgery, sponsored by Catharina Ziekenhuis Eindhoven. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Catharina Ziekenhuis Eindhoven · Not applicable, Interventional, and Treatment
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.
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.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 250 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
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Exclusion Criteria:
A potential participant who meets any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Total arterial, anaortic off-pump ccoronary artery bypass grafting through median sternotomy.
Procedure: Off-pump coronary arterial bypass grafting (OPCAB)
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.
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.
Composite Absence of Adverse Events within 30 Days Postoperatively (Textbook Outcome)
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
Time frame: 30 days postoperatively
Conversion to Sternotomy
Rate of conversion to sternotomy for minimally invasive coronary surgery (MICS) patients.
Time frame: Peri-operatively
Conversion to Cardiopulmonary Bypass
Incidence of hemodynamic support with cardiopulmonary bypass during the surgical procedures.
Time frame: Peri-operatively
Intensive Care Unit (ICU) Stay
Duration of ICU stay following the surgical procedure (in days).
Time frame: 30 days postoperatively
Postoperative Hospital Stay
Total length of postoperative hospital stay (in days).
Time frame: 30 days postoperatively
Mechanical Ventilation Time
Total ventilation time during the postoperative period (in hours).
Time frame: 30 days postoperatively
Postoperative Blood Loss
Total volume of postoperative blood loss (in milliliters) postoperatively.
Time frame: 30 days postoperatively
Transfusion Requirement
Need for transfusion of blood products (packed units of thrombocyt, red blood cells and plasma) during the postoperative period
Time frame: 30 days postoperatively
Phrenic Nerve Injury
Incidence of phrenic nerve injury leading to diaphragm paralysis.
Time frame: 30 days postoperatively
Postoperative Peak Expiratory Flow (PEF)
PEF measurement at Day 1 and Day 3 postoperatively, and at 4 weeks post-discharge.
Time frame: 30 days postoperatively
Quality of Life Assessment (EQ-5D)
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
Time frame: 1 year
Angina Assessment (CCS Classification)
Assessment of angina using the Canadian Cardiovascular Society (CCS) classification at baseline, discharge and every 3 months for up to 1 year
Time frame: 1 year
Short-term Healthcare Costs
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).
Time frame: 30 days
Long-term Healthcare Costs
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).
Time frame: 1 year
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Incidence of MACCE including mortality, stroke and myocardial infarction up to 5 years post-procedure.
Time frame: 5 years
Target Vessel Revascularization (TVR)
Incidence TVR up to 5 years post-procedure.
Time frame: 5 year
Plan to share: Undecided — IPD could be made available upon request to the Principal Investigator after the study's completion.
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Catharina Ziekenhuis Eindhoven