New ultrasound technique aims to save limbs in artery disease patients
NCT ID NCT06979284
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
This study tests whether using a tiny ultrasound camera inside the leg arteries during a procedure to open blockages can prevent major problems like amputation or the artery narrowing again. About 772 adults with severe peripheral artery disease (chronic limb-threatening ischemia) will be randomly assigned to get the standard X-ray guidance or the extra ultrasound guidance. The goal is to see if the ultrasound approach leads to fewer serious events over time.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 772 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Oct 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients presenting with lower extremity PAD manifesting as CLTI: a. CLTI is defined as ischemic rest foot pain, nonhealing wounds, or gangrene present for at least two weeks and that is attributable to objectively proven arterial occlusive disease, compatible with Rutherford class 4, 5 or 6 AND 2. Scheduled to undergo percutaneous revascularization, AND 3. Informed consent 4. Imaging evidence of an obstructive or occluded lesion (\> 70%) in the infraiguinal circulation (e.g. femoral, popliteal, or infrapopliteal circulation) using angiography, ultrasound, computed tomography, or magnetic resonance imaging that is responsible for CLTI of the index limb 5. An infrapopliteal lesion must be located in the proximal 2/3 of native infrapopliteal vessels, with a vessel diameter of \> 2.5mm by investigator visual assessment. 6. The distal margin of the most distal target lesion must be located \> 10 cm proximal to the proximal margin on the ankle mortise. The vessel segment distal to the most distal target lesion must be patent all the way to the ankle, with no obstructive lesion (\>50% stenosis). Exclusion Criteria: 1. The presence of anatomic or comorbid conditions or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the potential participant's ability to participate in the trial or to comply with the follow-up requirements. 2. The presence of any medical conditions precluding percutaneous revascularization 3. The subject has previously had or requires open surgical revascularization involving the vessel containing the target lesion of the ipsilateral extremity. 4. The subject is bedridden or unable to walk (with assistance is acceptable). 5. Life expectancy \< 12 months 6. Age \< 18 years 7. Active vasculitis, Buerger's disease, or acute limb-threatening ischemia 8. Planned above-ankle amputation of the index limb within four weeks of the index procedure. 9. Obstructive supra-inguinal "inflow" (\>70% stenosis) which is not planned to be treated during index procedure or within 30 days of the index procedure. 10. The subject has had any amputation to the ipsilateral extremity other than the toe or forefoot, or the subject has had a major amputation to the contralateral extremity \< 1 year before the index procedure and is not independently walking. 11. Extensive tissue loss that is salvageable only with complex foot reconstruction or non-traditional trans metatarsal amputations. 1. Osteomyelitis that extends proximal to the metatarsal heads 2. Gangrene involving the plantar skin of the forefoot, midfoot or heel 3. Deep ulcer or large shallow ulcer (\> 3 cm) involving the plantar skin of the f forefoot, midfoot, or heel 4. Full-thickness heel ulcer 5. Any wound with calcaneal bone involvement 6. Wounds that would require flap coverage or complex wound management for large soft tissue defect 7. Full-thickness wounds on the dorsum of the foot with exposed tendon or bone.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centre Hospitalier De L'Universite De Montreal (CHUM)
RECRUITINGMontreal, Quebec, Canada
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Centre Hospitalier Universitaire de Sherbrooke
RECRUITINGSherbrooke, Quebec, Canada
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Hamilton General Hospital
RECRUITINGHamilton, Canada
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The Sir Mortimer B. Davis Jewish General Hospital
RECRUITINGMontreal, Quebec, Canada
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Unity Health Toronto - St. Micheal's Hospital
RECRUITINGToronto, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- A window into living tissue: new sensor may spot dangerous oxygen drops during surgery
- Can a flash of light reveal how well angioplasty restores blood flow in diabetic feet?
- Shockwave vs. drill: which method best prepares calcified heart arteries for stents?
- Can a sound wave camera inside arteries save more legs?