Coronary Artery Disease Clinical Trial
Official title:
Comparative Effectiveness of the Minimally Invasive Coronary Artery Bypass Grafting (MICS CABG) Versus Off Pump (OPCABG) and on Pump Coronary Artery Bypass Grafting (ONCABG) in Patients With Multi-vessel Coronary Disease
The purpose of this study is to compare three different revascularization strategies in
patients with multi-vessel coronary disease: MICS CABG, OPCABG and ONCABG.
The study hypothesis: MICS CABG (Minimally invasive cardiac surgery coronary artery bypass
grafting) has advantages in comparison with conventional off-pump (OPCABG) and on-pump
coronary artery bypass grafting (ONCABG) concerning major adverse cardiac and cerebral
events (MACCE) and procedural success.
Prospective, single-center, randomized trial, intended to compare three different
revascularization strategies in patients with multi-vessel coronary artery disease:
1. MICS CABG. Minimally invasive cardiac surgery coronary artery bypass grafting (complete
multivessel minimally invasive off-pump revascularization via left minithoracotomy).
(MICS CABG group, n=50).
2. OPCABG. Off-pump coronary artery bypass grafting treatment (OPCABG group, n=50).
3. ONCABG. On-pump coronary artery bypass grafting treatment (ONCABG group, n=50). The
endpoints: The primary endpoints will be death, MI, stroke, or new myocardial ischemia
and will be target vessel revascularization and non-target vessel revascularization at
30 days, 12 months and 3-year follow-up.
The secondary endpoints: Procedural success, Procedural and post-procedural blood loss and
number of transfusions, Wound complications, Recovery time, Heart Failure (New York Heart
Association (NYHA)), Life quality assessed by one of the life quality questionnaires.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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