Coronary Artery DiseaseCOMFORTNCT07720661
Comparative Outcomes of Mammary Artery Harvesting: Infection, Occlusion Rates and Thoracic Pain Assessment
A study testing Skeletonized LIMA Harvesting and Non-Skeletonized LIMA Harvesting in people with Coronary Artery Disease and Coronary Artery Bypass Grafting, run by Hamilton Health Sciences Corporation.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Bypass Grafting, Surgical Site Infection
- What is being tested?
- Skeletonized LIMA Harvesting and Non-Skeletonized LIMA Harvesting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 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%)
Show all 12Show fewer
- 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
About this study
Official title: COMFORT: Comparative Outcomes of Mammary Artery Harvesting: Infection, Occlusion Rates and Thoracic Pain Assessment
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).
Read the detailed description
The COMFORT trial is an international, multicentre, blinded, expertise-based randomized controlled trial evaluating two commonly used techniques for harvesting the left internal mammary artery (LIMA) during coronary artery bypass grafting (CABG): skeletonized and non-skeletonized (pedicled) harvesting.
Although skeletonized harvesting has been associated with reduced sternal wound complications and postoperative pain, concerns have emerged regarding its potential impact on graft patency and long-term cardiovascular outcomes. Existing evidence is largely derived from observational studies and post hoc analyses, and no adequately powered randomized trial has prospectively compared these techniques using systematic imaging-based graft assessment.
The COMFORT trial will enroll approximately 1,116 patients undergoing isolated CABG with a planned LIMA-to-LAD graft. Participants will be randomly assigned to undergo either skeletonized or non-skeletonized LIMA harvesting performed by surgeons experienced in both techniques. Participants and outcome assessors will remain blinded to treatment allocation.
Participants will undergo protocol-mandated coronary computed tomography angiography (CTA) at 1.5 years after surgery, with follow-up extending to 2 years. Independent blinded committees and a central CTA core laboratory will adjudicate imaging and clinical outcomes. In addition to graft assessment, the study will evaluate the effects of harvesting technique on cardiovascular outcomes, sternal wound complications, chronic postoperative pain, quality of life, and healthcare resource utilization.
The findings of COMFORT are expected to provide definitive evidence to guide surgical practice and inform future guidelines regarding the optimal method of internal mammary artery harvesting during CABG surgery.
- Being tested
- Skeletonized LIMA Harvesting, Non-Skeletonized LIMA Harvesting
- Keywords
- CABG, Left Internal Mammary Artery, Skeletonized Harvesting
- Medical subject headings
- Coronary Artery Disease, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skeletonized LIMA HarvestingProcedure or surgery
Skeletonized (SK) harvesting of the left internal mammary artery (LIMA) to left anterior descending artery (LAD) graft: the LIMA is isolated without surrounding satellite veins, endothoracic fascia, and intercostal nerves
Non-Skeletonized LIMA HarvestingProcedure or surgery
Non-skeletonized (non-SK) harvesting of the LIMA-LAD graft: the LIMA is harvested with surrounding satellite veins, endothoracic fascia, and intercostal nerves (standard pedicled technique)
| Study group | Role | What they receive |
|---|---|---|
| Skeletonized LIMA Harvesting | Experimental | 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. Receives: Procedure: Skeletonized LIMA Harvesting |
| Non-Skeletonized LIMA Harvesting | Active 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. Receives: Procedure: Non-Skeletonized LIMA Harvesting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Graft Patency
Binary assessment of LIMA-LAD graft patency versus graft failure
Measured: 1.5 years after surgery
Secondary outcomes (3)
MACE
The composite of cardiovascular mortality, myocardial infarction, or repeat revascularization
Measured: 2 years after surgery
Number of Participants with a Sternal Surgical Site Infection
The composite of sternal surgical site infection
Measured: 90 days after surgery
Number of Participants with LIMA-LAD Driven Repeat Revascularization or Occlusion
Any coronary revascularization procedure (PCI or CABG) targeting the LIMA-LAD graft territory, or occlusion of the LIMA-LAD graft revealed by clinically indicated coronary angiography or CTA
Measured: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Why it stopped: Registered too early. Completing the vanguard first which is registered separately.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to undergo either skeletonized or non-skeletonized LIMA harvesting during CABG surgery and followed prospectively for comparison of graft patency, clinical outcomes, wound complications, pain, and quality of life between the two parallel treatment groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Population Health Research Institute
- Responsible party
- Sponsor
- Investigators
- Andre Lamy, MD, Principal investigator, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720661
- Sponsor's protocol ID
- COMFORT
- Acronym
- COMFORT
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 28 Jul 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 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMFORT: Comparative Outcomes of Mammary Artery Harvesting: Infection, Occlusion Rates and Thoracic Pain Assessment
- ClinicalTrials.gov ID
- NCT07720661
- Acronym / sponsor ID
- COMFORT / COMFORT
- Keywords
- CABG, Left Internal Mammary Artery, Skeletonized Harvesting
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Registered too early. Completing the vanguard first which is registered separately.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Population Health Research Institute
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 22 Jul 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 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).
Detailed description
The COMFORT trial is an international, multicentre, blinded, expertise-based randomized controlled trial evaluating two commonly used techniques for harvesting the left internal mammary artery (LIMA) during coronary artery bypass grafting (CABG): skeletonized and non-skeletonized (pedicled) harvesting.
Although skeletonized harvesting has been associated with reduced sternal wound complications and postoperative pain, concerns have emerged regarding its potential impact on graft patency and long-term cardiovascular outcomes. Existing evidence is largely derived from observational studies and post hoc analyses, and no adequately powered randomized trial has prospectively compared these techniques using systematic imaging-based graft assessment.
The COMFORT trial will enroll approximately 1,116 patients undergoing isolated CABG with a planned LIMA-to-LAD graft. Participants will be randomly assigned to undergo either skeletonized or non-skeletonized LIMA harvesting performed by surgeons experienced in both techniques. Participants and outcome assessors will remain blinded to treatment allocation.
Participants will undergo protocol-mandated coronary computed tomography angiography (CTA) at 1.5 years after surgery, with follow-up extending to 2 years. Independent blinded committees and a central CTA core laboratory will adjudicate imaging and clinical outcomes. In addition to graft assessment, the study will evaluate the effects of harvesting technique on cardiovascular outcomes, sternal wound complications, chronic postoperative pain, quality of life, and healthcare resource utilization.
The findings of COMFORT are expected to provide definitive evidence to guide surgical practice and inform future guidelines regarding the optimal method of internal mammary artery harvesting during CABG surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to undergo either skeletonized or non-skeletonized LIMA harvesting during CABG surgery and followed prospectively for comparison of graft patency, clinical outcomes, wound complications, pain, and quality of life between the two parallel treatment groups.
| Arm | Type | Receives |
|---|---|---|
| Skeletonized LIMA Harvesting | Experimental | Procedure: Skeletonized LIMA HarvestingHarvesting 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. |
| Non-Skeletonized LIMA Harvesting | Active comparator | Procedure: Non-Skeletonized LIMA HarvestingConventional 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. |
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 (12 listed)
- 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
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 LIMA HarvestingSkeletonized (SK) harvesting of the left internal mammary artery (LIMA) to left anterior descending artery (LAD) graft: the LIMA is isolated without surrounding satellite veins, endothoracic fascia, and intercostal nerves | Procedure or surgery | Skeletonized LIMA Harvesting |
| Non-Skeletonized LIMA HarvestingNon-skeletonized (non-SK) harvesting of the LIMA-LAD graft: the LIMA is harvested with surrounding satellite veins, endothoracic fascia, and intercostal nerves (standard pedicled technique) | Procedure or surgery | Non-Skeletonized LIMA Harvesting |
Primary outcome
Number of Participants with Graft Patency
Time frame: 1.5 years after surgery
Binary assessment of LIMA-LAD graft patency versus graft failure
3 secondary outcomes
MACE
Time frame: 2 years after surgery
Number of Participants with a Sternal Surgical Site Infection
Time frame: 90 days after surgery
Number of Participants with LIMA-LAD Driven Repeat Revascularization or Occlusion
Time frame: 2 years after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 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. This study is not recruiting at the moment.
Andre Lamy, MD principal investigator
Population Health Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Skeletonized LIMA Harvesting and Non-Skeletonized LIMA Harvesting in people with Coronary Artery Disease and Coronary Artery Bypass Grafting, run by Hamilton Health Sciences Corporation.
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 12 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: withdrawn, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Graft Patency (time frame: 1.5 years after surgery). 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 28 Jul 2026.