The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Trial
NCT ID: NCT03447938
Last Updated: 2024-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
176 participants
INTERVENTIONAL
2018-09-01
2028-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CABG with sternotomy
Patients in this group will undergo coronary artery bypass grafting (CABG) in the usual way, through an incision in the middle of the chest, through the breastbone or sternum (conventional CABG).
Conventional CABG
Coronary artery bypass grafting performed through an incision through the sternum or breastbone.
Minimally-invasive CABG
Patients in this group will undergo coronary artery bypass grafting (CABG) using a minimally-invasive approach (MICS CABG), through smaller incisions between the ribs.
MICS CABG
Coronary artery bypass grafting performed through small incisions between the ribs.
Interventions
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MICS CABG
Coronary artery bypass grafting performed through small incisions between the ribs.
Conventional CABG
Coronary artery bypass grafting performed through an incision through the sternum or breastbone.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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London Health Sciences Centre
OTHER
Heart Center Leipzig - University Hospital
OTHER
Fortis Escorts Heart Institute
OTHER
The Methodist Hospital Research Institute
OTHER
Carolinas Medical Center
OTHER
Gundersen Lutheran Health System
OTHER
Jilin Heart Hospital
OTHER
Far Eastern Memorial Hospital
OTHER
Medtronic
INDUSTRY
Apollo Hospitals Enterprise Limited
OTHER
Fresno Heart and Surgical Hospital
UNKNOWN
Ichinomiya-Nishi Hospital
UNKNOWN
Ottawa Heart Institute Research Corporation
OTHER
Responsible Party
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Principal Investigators
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Marc Ruel, MD
Role: PRINCIPAL_INVESTIGATOR
Ottawa Heart Institute Research Corporation
Locations
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Universitaire Ziekenhuizen Leuven
Leuven, , Belgium
Division of Cardiac Surgery, University of Ottawa Heart Institute
Ottawa, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Jilin Heart Hospital
Jilin, Jilin, China
Leipzig Heart Institute GmbH
Leipzig, Saxony, Germany
Robert-Bosch-Hospital
Stuttgart, , Germany
Apollo Hospital, Bangalore
Bangalore, Karnataka, India
Manipal Hospitals
New Delhi, National Capital Territory of Delhi, India
Tokyo Bay Urayasu Ichikawa Medical Center
Urayasu, Chiba, Japan
National University Hospital (NUH) - Singapore
Singapore, , Singapore
Far-Eastern Memorial Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Johannes Bonatti, MD
Role: primary
Role: backup
Prem Rabindra, MD
Role: primary
Piroze Davierwala, MD
Role: primary
Role: backup
Massimo Lemma, MD
Role: primary
Marc Albert, MD
Role: primary
Role: backup
Sathyaki Nambala
Role: primary
Yugal Mishra, MD
Role: primary
Kuan-Ming Chiu, MD
Role: primary
Other Identifiers
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20180008
Identifier Type: -
Identifier Source: org_study_id
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