Recruiting

LIMA Approaches

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT07599553

Conditions

Graft Patency

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Skeletonized vs non-skeletonized harvesting of the left internal mammary artery

Study Details

Brief summary:

The Pilot study for the COMFORT Trial is a single centre trial to determine the feasibility of the full COMFORT Trial.

The main COMFORT Trial will be a multi-centre trial to investigate the coronary artery bypass grafting outcomes when harvesting the Left Internal Mammary Artery (LIMA) using a skeletonized approach (artery is isolated without the surrounding veins, fascia and nerves) compared to harvesting the LIMA using a non-skeletonized approach (artery is isolated with the surrounding veins, fascia and nerves). Harvesting the LIMA with the non-skeletonized approach is the standard technique. Participants will complete a Coronary Artery Tomography scan at 1 year to determine if the LIMA graft remains open. Follow up of the participants will continue until 2 years post surgery.

Conditions

Graft Patency

Study ID

NCT07599553

Start date

Aug 31, 2026

Status verified date

Sep, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

35 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Skeletonized Harvesting of LIMA

LIMA is harvested using the skeletonized harvesting technique. This technique isolates the artery without the surrounding satellite veins, endothoracic fascia, and intercoastal nerves.

active comparator: Non-Skeletonized Harvesting of LIMA

LIMA is harvested using the non-skeletonized harvesting technique. This technique isolates the artery with the surrounding satellite veins, endothoracic fascia, and intercoastal nerves.

Interventions

Skeletonized vs non-skeletonized harvesting of the left internal mammary artery

This intervention is the surgical technique used to harvest the artery that will be used to perform the bypass surgery.

Primary outcome measure

  • Feasibility of Implementation [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Nahya Awada, BSN, MCR, Ph.D.

613-696-7000naawada@ottawaheart.ca

Locations

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Contacts

Nahya Awada, BSN, MCR, Ph.D.

613-696-7000naawada@ottawaheart.ca

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • bypass graft harvesting
  • skeletonized harvesting
  • non-skeletonized harvesting
  • CABG surgery
  • Left Internal Mammary Artery
  • LIMA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2026-09-08.