Multivessel Hybrid Revascularization for Three-Vessel CAD vs Conventional Off-Pump CABG

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter randomized trial enrolling patients with three-vessel coronary disease to compare multivessel hybrid coronary revascularization (MICS-based arterial grafting to the LAD and LCx, plus PCI to the RCA) against conventional off-pump CABG via median sternotomy. The primary endpoint is a 30-day Textbook Outcome, a composite of death, myocardial infarction, stroke, re-exploration for bleeding, and other major complications. The study aims to determine if the hybrid approach improves perioperative recovery and long-term cardiovascular outcomes while reducing surgical trauma. Enrollment targets 250 participants across participating centers. Outcomes will inform whether multivessel-HCR can be a preferred revascularization strategy for complex three-vessel disease.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Hospitals Leuven
  Leuven, Vlaams Brabant, Belgium Recruiting
• Catharina Hospital Eindhoven
  Eindhoven, Eindhoven, Netherlands Recruiting

Study contacts

• Principal investigator: Ferdi Akca, MD, PhD — Catharina Ziekenhuis Eindhoven
• Study coordinator: Ferdi Akca, MD, PhD
• Email: ferdi.akca@catharinaziekenhuis.nl
• Phone: +31 40 239 9111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.