Feasibility check of skeletonized vs non-skeletonized left internal mammary artery harvesting in heart surgery
Official title: Pilot Study for COMFORT Trial Comparative Outcomes of Mammary Artery Harvesting: Infection, Occlusion Rates and Thoracic Pain Assessment
Run by Ottawa Heart Institute Research Corporation · NCT07599553 · Data updated 2026-11-12
This pilot test compares two ways of taking the left internal mammary artery during CABG to see which approach is feasible to study further and how it affects graft patency and patient experience.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 35 (estimated) |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Ottawa, Ontario) |
| Status | Recruiting |
| Started | August 31, 2026 |
| Main results expected | September 2027 |
| Study ends | June 2028 |
| Registry record updated | September 8, 2026 |
| Trial ID | NCT07599553 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older undergoing isolated CABG with planned LIMA-LAD graft at participating centers.
✕Probably not a fit
Patients not meeting eligibility or undergoing non-sternotomy approaches, emergency surgery, or with significant contraindications to the study procedures may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The pilot phase is a single-center feasibility study to prepare for a larger, multi-center COMFORT trial. It will randomize patients undergoing CABG with planned LIMA-LAD graft to skeletonized or non-skeletonized harvesting, collect intraoperative data, and ensure proper data collection and follow-up, including a 1-year CTA to assess graft patency and up to 2 years of follow-up. The study will also evaluate recruitment, consent, randomization workflows, and accreditation of procedures across sites before broader rollout. Data from this pilot may contribute to the overall COMFORT trial dataset if aligned with the final protocol and analysis plan.
Why it matters
Potential benefit: If successful, the trial could clarify whether skeletonized LIMA harvesting is feasible to study at scale and inform future practices to optimize graft patency and patient outcomes.
How similar studies have gone: Prior work in CABG techniques has explored LIMA harvesting methods, but this specific feasibility pilot for a multi-center randomized comparison is novel in its scope and protocol alignment.
Who can join: the full rules
Show full inclusion / exclusion 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 or presentation * History of prior ternotomy * 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 contraindications to CTA contrast). The eGFR will be determined by each participating institution according to their standard practice.
Where it's running
-
University of Ottawa Heart Institute
Ottawa, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Fraser Rubens, MD, MSc. — Ottawa Heart Institute Research Corporation
- Study coordinator: Nahya Awada, BSN, MCR, Ph.D.
- Email: naawada@ottawaheart.ca
- Phone: 613-696-7000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.