Intravascular Ultrasound for Peripheral Artery Disease Revascularization
772 participantsStarted 2025-07-01
Plain-language summary
The purpose of this study is to determine if IVUS use, as compared to angiography alone, prevent major adverse limb events (MALE) or binary restenosis (a greater than 50% re-narrowing of the treated artery) in adult patients who have CLTI and are undergoing percutaneous revascularization.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Patients presenting with lower extremity PAD manifesting as CLTI:
ā. Scheduled to undergo percutaneous revascularization, AND
ā. Informed consent
ā. 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.
ā. 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.
ā. 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
ā. 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.
ā. The presence of any medical conditions precluding percutaneous revascularization
ā. The subject has previously had or requires surgical revascularization involving the vessel containing the target lesion of the ipsilateral extremity.
ā. The subject is bedridden or unable to walk (with assistance is acceptable).
What they're measuring
1
Time-to-first occurrence of MALE
Timeframe: From date of randomization until the date of first unplanned above ankle amputation of the index limb, clinically driven target lesion revascularization or target-lesion binary restenosis, assessed up to a maximum of 5 years.