An interventional study of Skeletonized vs non-skeletonized harvesting of the left internal mammary artery in Graft Patency, sponsored by Ottawa Heart Institute Research Corporation. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Ottawa Heart Institute Research Corporation · Not applicable, Interventional, and Other
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.
Prior to expansion of the COMFORT Trial to multiple centres, a pilot phase will be conducted at UOHI to evaluate the feasibility of implementing the study protocol within the local clinical and research environment.
Conducting an initial pilot phase allows the study team to assess the practical aspects of trial implementation, including patient screening and recruitment, informed consent procedures, randomization workflow, intraoperative documentation of the harvesting technique, and completion of study data collection.
The pilot phase will also allow evaluation of study logistics related to follow-up procedures, including postoperative data collection and coordination of protocol-mandated computed tomography angiography (CTA). This process will help identify and address any operational challenges prior to broader trial implementation across participating centres.
Participants enrolled during the pilot phase will undergo the same randomized study procedures described in the main COMFORT Trial protocol. Data collected during this phase may contribute to the overall COMFORT Trial dataset, subject to confirmation that the pilot procedures align with the finalized trial protocol and statistical analysis plan.
Exclusion Criteria:
LIMA is harvested using the skeletonized harvesting technique. This technique isolates the artery without the surrounding satellite veins, endothoracic fascia, and intercoastal nerves.
Procedure: Skeletonized vs non-skeletonized harvesting of the left internal mammary artery
LIMA is harvested using the non-skeletonized harvesting technique. This technique isolates the artery with the surrounding satellite veins, endothoracic fascia, and intercoastal nerves.
Procedure: 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.
Feasibility of Implementation
Combined assessment of screening, recruitment, randomization, surgical protocol adherence, and completion of study data collection and follow up procedures.
Time frame: 2 years
Recruitment Rate
Measurement of rate of participant enrollment to determine ability to efficiently recruit into the main trial.
Time frame: Activation of study to 6 months.
Protocol Adherence
Ability to complete all protocol required tests and assessments.
Time frame: activation to 2 years per participant.
Completeness of Study Data Collection
Measurement of ability to collect all protocol-required data.
Time frame: activation to 2 years per participant.
Completion of CTA at 1 year.
Feasibility of completing the CTA at 1 year for all participants.
Time frame: enrollment to 1 year.
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Ottawa Heart Institute Research Corporation