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Recruiting NCT07314138

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

Conditions: Coronary Artery Disease (CAD), Bypass, Cardiopulmonary, Minimally Invasive Coronary Revascularization Surgery, Off-pump Coronary Artery Bypass

Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 250
Sponsor: Catharina Ziekenhuis Eindhoven

Location: University Hospitals Leuven Leuven Vlaams Brabant

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 Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07314138). StuddyBuddy aggregates publicly available trial information.