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