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

Eligibility Criteria

• * Age of subject is ≥ 18.
• * Estimated life expectancy ≥1 year.
• * Subject is able and willing to comply with all assessments in the study.
• * Subject has been informed of the nature of the study, agrees to participate, and has signed the approved consent form.
• * Rutherford Category classification of 4 or 5 of the target limb.
• * Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guidelines.
• * Target lesion that is located in a native, de novo infra-popliteal artery (extending from P3 of the popliteal artery to the margin of the ankle mortise).
• * Target lesions(s) must be viewed angiographically and have 50-100% stenosis.
• * Only a single lesion is allowed per subject.
• * The vessel segment distal to the target lesion must be patent all the way to the ankle, with no significant lesion (≥ 50% stenosis).
• * Lesion length ≥50mm and ≤300mm.
• * Intraluminal crossing of the lesion. Successful crossing is defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations. If this is not certain, IVUS or OCT may be used to verify this at the operator's discretion.
• * Target Lesion reference vessel diameter (RVD) between 1.5mm - 4.5mm by investigator estimate.
• * Subject has at least one patent tibial vessel on the target leg with 1-vessel runoff to the foot, defined as stenosis ≤50%.
• * 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 contralateral iliac, ipsilateral iliac, femoral, or P1-P2 segments of the popliteal arteries with ≤30
• * Residual stenosis, and/or serious angiographic complications (e.g., embolism) prior to the investigational device usage.
• * Failure to perioperatively successfully treat significant non-target infra-popliteal lesions prior to treatment of the target lesion (during the index procedure). Successful treatment is defined as obtaining ≤50% residual stenosis with no serious angiographic complications (e.g., embolism).
• * The use of drug-eluting balloons, re-entry or other atherectomy devices.