Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone

Exclusion Criteria24

• Target lesion is in a vessel graft or synthetic graft.
• Treatment of target lesion with radial access.
• Planned target limb major amputation (above-the-ankle).
• Acute limb ischemia or required thrombolysis as a primary treatment modality of the target limb.
• History of prior endovascular or surgical procedure on the index limb within 30 days prior to enrollment or planned within 30 days of the index procedure.
• Subject is pregnant or breastfeeding. (Female subjects of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure.)
• Subject has a known coagulopathy or has bleeding diatheses/disorder, thrombocytopenia with platelet count less than 100,000/microliter / less than 80,000K.
• Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
• Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
• Myocardial infarction within 60 days prior to enrollment.
• History of stroke/CVA/TIA within 60 days prior to enrollment.
• History of thrombolytic therapy within 14 days of enrollment.
• Subject has acute or chronic renal disease defined as serum creatinine of \>2.5 mg/dL or \>220 umol/L, or is on dialysis.
• Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
• Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the study requirements and evaluations pre- and post-treatment.
• Subject experiencing ongoing cardiac problems that per the investigator judgment would not make the subject ideal per the procedure.
• Subject has evidence of intracranial or gastrointestinal bleeding within the past 3 months.
• Failure to treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or P1-P2 segments of the popliteal arteries with \<50% residual stenosis with no serious angiographic complications (e.g., embolism or dissection) prior to treatment of the target lesion.
• Residual stenosis, and/or serious angiographic complications (e.g., embolism) prior to the investigational device usage.
• The use of adjunctive devices to treat the target lesion other than the investigative Auryon laser catheter and/or PTA devices, such as scoring balloons, drug-eluting balloons, re-entry devices, lithotripsy devices, or other atherectomy devices (with the exception of bailout stents for Class C/D dissections).
• Subjects that do not meet eligibility criteria for the randomized controlled trial are eligible to be enrolled in the observational study.
• Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Auryon Atherectomy System as per Instructions for Use (IFU) or investigator's opinion.
• Subject is pregnant or breastfeeding. (Female subjects of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure.)
• Subject is already enrolled in other investigational (interventional) studies that would interfere with study endpoints.