IVUS-guided revascularization for leg arteries in CLTI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares IVUS-guided revascularization to angiography-only approaches in adults with chronic limb-threatening ischemia due to peripheral arterial disease. Participants must have obstructive infrainguinal disease and be scheduled for percutaneous revascularization. The trial aims to see if IVUS can lower major adverse limb events and binary restenosis, defined as more than 50% re-narrowing, in the treated limb. The study is conducted at Canadian centers, with specific arterial lesion and anatomical criteria to select eligible patients. Outcomes focus on limb-related events and restenosis following the procedure.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centre Hospitalier De L'Universite De Montreal (CHUM)
  Montreal, Quebec, Canada Recruiting
• The Sir Mortimer B. Davis Jewish General Hospital
  Montreal, Quebec, Canada Recruiting
• Centre Hospitalier Universitaire de Sherbrooke
  Sherbrooke, Quebec, Canada Recruiting
• Hamilton General Hospital
  Hamilton, Canada Recruiting
• Unity Health Toronto - St. Micheal's Hospital
  Toronto, Canada Recruiting

Study contacts

• Study coordinator: CLARITY Project Office
• Email: CLARITY@phri.ca
• Phone: 905-521-2100

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Vessel recoil after below-the-knee revascularization in high-risk CLTI patients

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.