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.
Scheduled to undergo percutaneous revascularization, AND
Informed consent
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.
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.
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.
The presence of any medical conditions precluding percutaneous revascularization
The subject has previously had or requires surgical revascularization involving the vessel containing the target lesion of the ipsilateral extremity.
The subject is bedridden or unable to walk (with assistance is acceptable).
Hamilton Health Sciences Corporation
Lead sponsor