Clinical Research Directory

Inclusion Criteria * Study participant is ≥ 18 years and ≤ 99 years old * Lesion(s) in the infrainguinal arteries: * Lesion above the knee (ATK): Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau) * Lesion below the knee (BTK): Target lesions involve arteries below the tibial plateau * RVD 2-7mm * De novo stenotic, restenotic post POBA, or occlusive lesion(s) * Target lesion must have angiographic evidence of ≥70% stenosis * Lesion length ≥ 3cm * Successful crossing of the target lesion with the guide wire * Successful predilatation, defined as residual stenosis \<50% Rutherford Class 2-5 * Study participant is able to provide consent and has signed and dated the informed consent form Exclusion criteria * Life expectancy ≤ 1 year * Study participant is currently participating in another investigational drug or device study that has not reached its primary endpoint yet. * Study participant is pregnant, planning to become pregnant, or father children during the course of the study. * Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion). * Prior bypass surgery of target vessel * Planned major amputation of the target limb * Thrombus in the target vessel * Known allergy to contrast media that cannot be adequately controlled with premedication * Study participant has a single target lesion that involves both ATK and BTK segments