The THOR IDE Study

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 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 Exclusion Criteria: * Patient has active infection requiring antibiotic therapy * Stenting planned within the target lesion * Known positive for COVID-19 within the last 2 weeks and a…