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 — PROCEDURE
    Skeletonized (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 — PROCEDURE
    Non-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 Harvesting
    Harvesting 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 Harvesting
    Conventional 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

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