Comparative Outcomes of Mammary Artery Harvesting: Infection, Occlusion Rates and Thoracic Pain Assessment
- Sponsor
- Hamilton Health Sciences Corporation
- Study ID
- NCT07720661
- Status
- Not Yet Recruiting
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Conditions
- Coronary Artery Bypass Grafting
- Coronary Artery Disease
- Surgical Site Infection
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Skeletonized LIMA Harvesting — PROCEDURESkeletonized (SK) harvesting of the left internal mammary artery (LIMA) to left anterior descending artery (LAD) graft: the LIMA is isolated without surrounding satellite veins, endothoracic fascia, and intercostal nerves
- Non-Skeletonized LIMA Harvesting — PROCEDURENon-skeletonized (non-SK) harvesting of the LIMA-LAD graft: the LIMA is harvested with surrounding satellite veins, endothoracic fascia, and intercostal nerves (standard pedicled technique)
Study Details
The COMFORT Trial is a randomized controlled superiority trial comparing skeletonized (SK) versus non-skeletonized (non-SK) harvesting of the left internal mammary artery (LIMA) to left anterior descending artery (LAD) graft in patients undergoing isolated coronary artery bypass grafting (CABG).
Key Dates
- First listed
- Jul 22, 2026
- Start date
- Sep 1, 2026
- Status verified
- Jul 2026
- Primary completion
- Dec 31, 2028
- Completion
- Apr 30, 2029
Study Design
- Enrollment
- 1,116 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Skeletonized LIMA HarvestingHarvesting of the left internal mammary artery as a skeletonized conduit during CABG surgery, with removal of surrounding tissues while preserving the artery as an isolated graft conduit.
- Active Comparator: Non-Skeletonized LIMA HarvestingConventional pedicled harvesting of the left internal mammary artery during CABG surgery, with preservation of the surrounding veins, fascia, and supporting tissues around the graft conduit.
Primary Outcome Measure
Graft Patency [ Time Frame: 1.5 years after surgery ]
Central Contacts
- Ingrid Copland905-296-5754
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