Comparative Outcomes of Mammary Artery Harvesting: Infection, Occlusion Rates and Thoracic Pain Assessment

NCT07720661 | Withdrawn DMC

• 1 other identifier: COMFORT
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Coronary Artery Disease; Coronary Artery Bypass Grafting; Surgical Site Infection

Keywords

CABG; Left Internal Mammary Artery; Skeletonized Harvesting

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Graft Patency

  Binary assessment of LIMA-LAD graft patency versus graft failure

  1.5 years after surgery

Secondary Outcomes (3)

• MACE

  2 years after surgery

• Number of Participants with a Sternal Surgical Site Infection

  90 days after surgery

• Number of Participants with LIMA-LAD Driven Repeat Revascularization or Occlusion

  2 years after surgery

Study Arms (2)

Skeletonized LIMA Harvesting

EXPERIMENTAL

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.

Procedure: Skeletonized LIMA Harvesting

Non-Skeletonized LIMA Harvesting

ACTIVE COMPARATOR

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.

Procedure: Non-Skeletonized LIMA Harvesting

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

Skeletonized LIMA Harvesting

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)

Non-Skeletonized LIMA Harvesting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Undergoing isolated CABG surgery with median sternotomy and a planned LIMA-LAD graft
• Provision of written informed consent

You may not qualify if:

• Non-sternotomy surgical approach (e.g., minimally invasive, thoracotomy)
• Emergency surgery (defined as surgery required within 24 hours of presentation)
• History of prior sternotomy
• Currently receiving systemic antibiotics or with an active bacterial infection at the time of surgery
• History of chronic sternal pain prior to the index surgery
• Known left subclavian artery stenosis (\>50%)
• Previous radiation therapy to the chest
• Known allergy or contraindication to iodinated contrast media that cannot be managed with premedication
• Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m² at baseline (relative contraindication to CTA contrast) as determined based on each centre's laboratory standard.
• Known pregnancy or plans for pregnancy during the study period
• Life expectancy less than 1.5 years due to non-cardiac conditions
• Inability or unwillingness to comply with follow-up procedures including CTA at 1.5 years

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Population Health Research Institute: collaborator

MeSH Terms

Conditions

Coronary Artery Disease; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andre Lamy, MD

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, data collectors, research coordinators, outcome adjudicators, CTA core laboratory readers, and statisticians are blinded to treatment allocation. Only the operating surgeon and operating room staff are aware of the assigned harvesting technique. CTA images are de-identified prior to core laboratory review, and outcome adjudication is performed by blinded independent committees.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to undergo either skeletonized or non-skeletonized LIMA harvesting during CABG surgery and followed prospectively for comparison of graft patency, clinical outcomes, wound complications, pain, and quality of life between the two parallel treatment groups.

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: July 28, 2026

Record last verified: 2026-07