The THOR IDE Study
The goal of this clinical trial is to test the Thor system in adult (≥ 18 year old) patients with de novo (new, never treated) calcified lesions in infrainguinal (leg) arteries (peripheral artery disease or PAD). The main question\[s\] it aims to answer are: * Is the Thor system safe in treating these lesions * Does the Thor system work to treat these lesions Participants will: * Receive treatment with the Thor system * Have follow-up visits at Discharge, 30 days, 6 months, and 12 months
• Patient age is ≥18 years
• Patient agrees to participate and to comply with the protocol by signing an IRB approved patient consent form
• Patient is able to walk unassisted or with non-motorized assistive devices
• Patient has PAD with documented Rutherford Class 2-4 of the target limb
• Anticipated life expectancy \>12 months, in the opinion of the investigator at the time of enrollment.
⁃ Angiographic Inclusion Criteria:
• Patient has de novo atherosclerotic disease of the native SFA and/or the popliteal arteries
• Target lesion has ≥70% diameter stenosis by investigator via visual assessment
• Target lesion length ≤150mm. Total treatment zone may not exceed 150mm, and may include one or more lesions.
• Chronic total occlusion lesion length is \<100mm of the total ≤150mm target lesion
• Minimum reference vessel diameter (RVD) 4.0mm by visual estimate
• Target lesion crossed and intraluminal guidewire placement confirmed; successful crossing defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations
• At least one patent tibial vessel (defined as \<50% stenosis) with runoff to the foot
• Target lesion has moderate to severe calcification graded using the Peripheral Academic Research Consortium (PARC) criteria