NCT07314138 Multivessel Minimally Invasive Coronary Bypass Grafting as HYBRID Revascularization Versus Conventional Off-pump Coronary Artery Bypass Grafting
| NCT ID | NCT07314138 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Catharina Ziekenhuis Eindhoven |
| Condition | Coronary Artery Disease (CAD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2026-08-25 |
| Primary Completion | 2029-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2026-08-25 with a primary completion date of 2029-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Ferdi Akca, MD, PhD
PRINCIPAL INVESTIGATOR
Catharina Ziekenhuis Eindhoven
Frequently Asked Questions
Who can join the NCT07314138 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Coronary Artery Disease (CAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07314138 currently recruiting?
Yes, NCT07314138 is actively recruiting participants. Contact the research team at ferdi.akca@catharinaziekenhuis.nl for enrollment information.
Where is the NCT07314138 trial being conducted?
This trial is being conducted at Leuven, Belgium, Eindhoven, Netherlands.
Who is sponsoring the NCT07314138 clinical trial?
NCT07314138 is sponsored by Catharina Ziekenhuis Eindhoven. The principal investigator is Ferdi Akca, MD, PhD at Catharina Ziekenhuis Eindhoven. The trial plans to enroll 250 participants.