Clinical Trials

Angiographic Inclusion Criteria:

• Patient has de novo atherosclerotic disease of the native SFA and/or the femoropopliteal arteries
• Target lesion has ≥70% diameter stenosis by investigator via visual assessment
• Target lesion length ≤150mm. Multiple lesions that are within a 150mm segment will be treated and assessed as a single lesion
• 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:

• Subject 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 enrollment
• Known contraindication to aspirin, 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 trial
• The use of specialty balloons, re-entry or additional atherectomy devices

Angiographic Exclusion Criteria:

• Subject has significant stenosis (>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g. iliac or common femoral) not successfully treated