Trial Parameters
Eligibility Fast-Check
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Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * 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