Graft PatencyCOMFORT pilotNCT07599553
Study of Feasibility for Surgical Patients Undergoing Heart Surgery With the Mammary Arteries: Reviewing Infection, Occlusion Rates and Pain Assessments.
A study testing Skeletonized vs non-skeletonized harvesting of the left internal mammary artery in people with Graft Patency, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Patency
- What is being tested?
- Skeletonized vs non-skeletonized harvesting of the left internal mammary artery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 31 Aug 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Undergoing isolated CABG surgery with median sternotomy and a planned LIMA-LAD graft.
- Provision of written informed consent.
Who cannot join
- 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%)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Nahya Awada, BSN, MCR, Ph.D., 613-696-7000, naawada@ottawaheart.ca
About this study
Official title: Pilot Study for COMFORT Trial Comparative Outcomes of Mammary Artery Harvesting: Infection, Occlusion Rates and Thoracic Pain Assessment
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.
Read the detailed description
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.
- Conditions
- Graft Patency
- Being tested
- Skeletonized vs non-skeletonized harvesting of the left internal mammary artery
- Keywords
- bypass graft harvesting, skeletonized harvesting, non-skeletonized harvesting, CABG surgery, Left Internal Mammary Artery, LIMA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skeletonized vs non-skeletonized harvesting of the left internal mammary arteryProcedure or surgery
This intervention is the surgical technique used to harvest the artery that will be used to perform the bypass surgery.
| Study group | Role | What they receive |
|---|---|---|
| Skeletonized Harvesting of LIMA | Experimental | LIMA is harvested using the skeletonized harvesting technique. This technique isolates the artery without the surrounding satellite veins, endothoracic fascia, and intercoastal nerves. Receives: Procedure: Skeletonized vs non-skeletonized harvesting of the left internal mammary artery |
| Non-Skeletonized Harvesting of LIMA | Active comparator | LIMA is harvested using the non-skeletonized harvesting technique. This technique isolates the artery with the surrounding satellite veins, endothoracic fascia, and intercoastal nerves. Receives: Procedure: Skeletonized vs non-skeletonized harvesting of the left internal mammary artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Implementation
Combined assessment of screening, recruitment, randomization, surgical protocol adherence, and completion of study data collection and follow up procedures.
Measured: 2 years
Secondary outcomes (4)
Recruitment Rate
Measurement of rate of participant enrollment to determine ability to efficiently recruit into the main trial.
Measured: Activation of study to 6 months.
Protocol Adherence
Ability to complete all protocol required tests and assessments.
Measured: activation to 2 years per participant.
Completeness of Study Data Collection
Measurement of ability to collect all protocol-required data.
Measured: activation to 2 years per participant.
Completion of CTA at 1 year.
Feasibility of completing the CTA at 1 year for all participants.
Measured: enrollment to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start31 Aug 2026
- Primary completionSep 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft PatencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization to one of two blinded study interventions
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Population Health Research Institute
- Responsible party
- Sponsor
- Investigators
- Fraser Rubens, MD, MSc., Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599553
- Sponsor's protocol ID
- 20260183-01H
- Acronym
- COMFORT pilot
- Status last verified
- Sep 2026
- First submitted
- 14 May 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for COMFORT Trial Comparative Outcomes of Mammary Artery Harvesting: Infection, Occlusion Rates and Thoracic Pain Assessment
- ClinicalTrials.gov ID
- NCT07599553
- Acronym / sponsor ID
- COMFORT pilot / 20260183-01H
- Conditions
- Graft Patency
- Keywords
- bypass graft harvesting, skeletonized harvesting, non-skeletonized harvesting, CABG surgery, Left Internal Mammary Artery, LIMA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- Population Health Research Institute
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomization to one of two blinded study interventions
| Arm | Type | Receives |
|---|---|---|
| Skeletonized Harvesting of LIMA | Experimental | Procedure: Skeletonized vs non-skeletonized harvesting of the left internal mammary arteryLIMA is harvested using the skeletonized harvesting technique. This technique isolates the artery without the surrounding satellite veins, endothoracic fascia, and intercoastal nerves. |
| Non-Skeletonized Harvesting of LIMA | Active comparator | Procedure: Skeletonized vs non-skeletonized harvesting of the left internal mammary arteryLIMA is harvested using the non-skeletonized harvesting technique. This technique isolates the artery with the surrounding satellite veins, endothoracic fascia, and intercoastal nerves. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Undergoing isolated CABG surgery with median sternotomy and a planned LIMA-LAD graft.
- Provision of written informed consent.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skeletonized vs non-skeletonized harvesting of the left internal mammary arteryThis intervention is the surgical technique used to harvest the artery that will be used to perform the bypass surgery. | Procedure or surgery | Non-Skeletonized Harvesting of LIMA, Skeletonized Harvesting of LIMA |
Primary outcome
Feasibility of Implementation
Time frame: 2 years
Combined assessment of screening, recruitment, randomization, surgical protocol adherence, and completion of study data collection and follow up procedures.
4 secondary outcomes
Recruitment Rate
Time frame: Activation of study to 6 months.
Protocol Adherence
Time frame: activation to 2 years per participant.
Completeness of Study Data Collection
Time frame: activation to 2 years per participant.
Completion of CTA at 1 year.
Time frame: enrollment to 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fraser Rubens, MD, MSc. principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skeletonized vs non-skeletonized harvesting of the left internal mammary artery in people with Graft Patency, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nahya Awada, BSN, MCR, Ph.D. (613-696-7000, naawada@ottawaheart.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Implementation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.