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

NCT07314138 · tracked via the Priya Life Science Netherlands tracker

Sponsor

Catharina Ziekenhuis Eindhoven

Phase

Not applicable

Started

2026-08-25

Last updated

2026-08-27

Condition(s) studied

Coronary Artery Disease (CAD)Bypass, CardiopulmonaryMinimally Invasive Coronary Revascularization SurgeryOff-pump Coronary Artery Bypass

Investigational drug(s) / intervention(s)

Multivessel Hybrid Coronary RevascularizationOff-pump coronary arterial bypass grafting (OPCAB)

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.

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.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

85 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Composite Absence of Adverse Events within 30 Days Postoperatively (Textbook Outcome) — 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

Trial sites (2)

Facility	City	Region	Status
University Hospitals Leuven	Leuven	Vlaams Brabant	Recruiting
Catharina Hospital Eindhoven	Eindhoven	Eindhoven	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07314138 on ClinicalTrials.gov ↗ ← All trials in the Netherlands