The THOR IDE Study

Eligibility 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
• * Life expectancy \>12 months
• * Patient has active infection requiring antibiotic therapy
• * Stenting planned within the target lesion
• * Known positive for COVID-19 within the last 2 weeks and actively symptomatic
• * Pregnant (positive pregnancy test) or currently breast feeding
• * Evidence of Acute Limb Ischemia within 7 days prior to procedure
• * Cerebrovascular accident (CVA) \<60 days prior to procedure
• * Myocardial infarction \<60 days prior to procedure
• * History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to baseline screening
• * Known contraindication to aspirin, or antiplatelet/anti-coagulant therapies required for procedure/follow-up
• * Known allergy to contrast media that cannot adequately be premedicated prior to study procedure
• * History of Thrombophilia, Heparin-induced Thrombocytopenia (HIT), or Heparin-induced Thrombotic Thrombocytopenia Syndrome (HITTS)
• * Serum creatinine ≥2.5mg/dL (unless dialysis-dependent) tested within a week prior to procedure
• * Planned lower limb major amputation (above the ankle)
• * Other surgical or endovascular procedure in the target limb that occurred within 14 days prior to index procedure or is planned for within 30 days following index procedure, with the exception of diagnostic angiography
• * Currently participating in any investigational device or drug clinical trial that, in the opinion of the investigator, will interfere with the conduct of the current study
• * The use of specialty balloons, re-entry or additional atherectomy devices is required