Comparative Outcomes of Mammary Artery Harvesting: Infection, Occlusion Rates and Thoracic Pain Assessment | NCT07720661

NCT07720661

Overview

NCT ID: NCT07720661
Lead Sponsor: Hamilton Health Sciences CorporationOTHER
Official Title: COMFORT: Comparative Outcomes of Mammary Artery Harvesting: Infection, Occlusion Rates and Thoracic Pain Assessment
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
Interventions

Status and Timeline

Status: Withdrawn
Last Update Posted: Jul 28, 2026Actual
Start Date: Sep 1, 2026Estimated
Primary Completion Date: Dec 31, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Age 18 years or older

Undergoing isolated CABG surgery with median sternotomy and a planned LIMA-LAD graft

Provision of written informed consent

Exclusion Criteria:

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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 0Actual
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Contacts and Locations

Central Contacts: No data available
Locations: No data available

Similar Studies

Participant Group/Arms

Skeletonized LIMA HarvestingExperimental

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 HarvestingActive 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