Actively Recruiting
Intravascular Ultrasound for Peripheral Artery Disease Revascularization: The CLARITY Randomized Controlled Trial
Led by Hamilton Health Sciences Corporation · Updated on 2026-06-08
772
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether using intravascular ultrasound (IVUS) during percutaneous revascularization can better prevent major adverse limb events (MALE) or significant artery narrowing (restenosis) compared to using angiography alone in adults with chronic limb threatening ischemia (CLTI) caused by peripheral arterial disease (PAD). The study aims to understand if IVUS guidance improves outcomes after artery treatment in this population. Participants will be randomly assigned to one of two groups: one receiving percutaneous revascularization guided by IVUS, where operators use ultrasound to optimize treatment of arteries hardened by calcium, and the other receiving standard care guided by angiography alone without IVUS. The procedures focus on unblocking arteries affected by PAD and CLTI. The study will follow participants for up to 5 years after treatment. Throughout the study, researchers will monitor participants regularly to track the time until the first major adverse limb event, including unplanned above-ankle amputations, need for additional artery treatment, or restenosis. They will also assess mortality, wound healing using the WIFI scale, walking ability, and vascular quality of life. Data will be collected up to five years post-randomization to evaluate long-term safety and effectiveness of the treatment strategies.
CONDITIONS
Brief Title
Intravascular Ultrasound for Peripheral Artery Disease Revascularization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with lower extremity peripheral arterial disease showing chronic limb threatening ischemia (CLTI) defined by rest foot pain, nonhealing wounds, or gangrene lasting at least two weeks, meeting specific pressure and pulse volume criteria
- Scheduled to undergo percutaneous revascularization
- Provided informed consent
- Imaging evidence of an obstructive or occluded lesion (>70%) in the infrainguinal circulation
- Infrapopliteal lesions located in the proximal two-thirds of native vessels with diameter >2.5 mm
- Distal margin of the most distal target lesion located >10 cm proximal to the ankle, with patent vessel segment distal to lesion
You will not qualify if you...
- Anatomic, medical, social, or psychological conditions limiting ability to participate or comply with follow-up
- Medical conditions preventing percutaneous revascularization
- Previous or planned surgical revascularization of the target vessel in the same leg
- Bedridden or unable to walk (assistance allowed)
- Life expectancy less than 12 months
- Age under 18 years
- Active vasculitis, Buerger's disease, or acute limb-threatening ischemia
- Planned above-ankle amputation within four weeks of the procedure
- Untreated obstructive supra-inguinal inflow (>70% stenosis) not planned for treatment
- Prior amputations to the ipsilateral leg other than toe/forefoot, or major contralateral amputation within one year with inability to walk independently
- Extensive tissue loss requiring complex foot reconstruction or non-traditional amputations, including osteomyelitis beyond metatarsal heads, gangrene involving plantar skin, large plantar ulcers (>3 cm), full-thickness heel ulcers, wounds with calcaneal bone involvement, wounds needing flap coverage or complex management, and full-thickness dorsal foot wounds exposing tendon or bone
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with immediate recovery
Participants undergo percutaneous revascularization either guided by intravascular ultrasound or by angiography as part of the standard care to unblock arteries affected by peripheral artery disease.
1 procedure visit (in-person)
Duration - Up to 5 years
Participants are followed for up to 5 years to monitor outcomes such as limb events, wound healing, quality of life, and survival after the revascularization procedure.
Periodic follow-up visits over 5 years
Trial Site Locations
Total: 2 locations
1
Hamilton General Hospital
Hamilton, Canada
Actively Recruiting
2
Unity Health Toronto - St. Micheal's Hospital
Toronto, Canada
Actively Recruiting
Research Team
C
CLARITY Project Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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