Status:
RECRUITING
The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Trial
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Collaborating Sponsors:
London Health Sciences Centre
Heart Center Leipzig - University Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
MICS CABG (Minimally invasive coronary surgery), where coronary artery bypass grafting (CABG) is completed through a small incision over the left chest, has evolved to become a safe and less invasive ...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Angiographically-confirmed multi-vessel coronary artery disease lesions with \>=70% in at least 2 major epicardial vessels in 2 or more coronary artery territories (left anterior descending (LAD), circumflex (CX) and right coronary artery (RCA)) OR lesions \>=50% in the left main (LM)
- Patients who, in the opinion of the investigator, are amenable for coronary surgery through either median sternotomy or minimally-invasive approach.
- Patients who are willing and able to comply with all follow-up study visits.
Exclusion
- \<18 years of age
- concomitant cardiac procedure with CABG (e.g. valve repair or replacement)
- Previous cardiac surgery, mediastinal irradiation, or significant trauma to the chest
- Contra-indications for MICS CABG, including: severe pectus excavatum; severe pulmonary disease; hemodynamically significant left subclavian stenosis; morbid obesity; severe left ventricular (LV) dysfunction; no adequate PDA or marginal branch target; absence of femoral pulse bilaterally.
- Contraindications for conventional CABG via sternotomy
- Concomitant life-threatening disease likely to limit life expectancy to \<2 years
- Emergency CABG with hemodynamic compromise
- Inability to provide informed consent.
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT03447938
Start Date
September 1 2018
End Date
March 1 2028
Last Update
January 10 2024
Active Locations (13)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
2
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
3
Universitaire Ziekenhuizen Leuven
Leuven, Belgium
4
Division of Cardiac Surgery, University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7