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

Inclusion 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 hassigned 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 theopinion of the investigator or per hospital guidelines.

Angiographic Inclusion Criteria

• Target lesion that is located in a native, de novo infra-popliteal artery (extendingfrom 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 included in the study per subject.

• The vessel segment distal to the target lesion must be patent all the way to theankle, with no significant lesion (≥ 50% stenosis).

• Lesion length ≥50mm and ≤300mm.

• Intraluminal crossing of the lesion. Successful crossing is defined as tip of theguidewire distal to the target lesion in the absence of flow limiting dissections orperforations. If this is not certain, IVUS or OCT may be used to verify this at theoperator's discretion.

• Target Lesion reference vessel diameter (RVD) between 1.5mm - 4.5mm by investigatorestimate.

Exclusion Criteria:

• 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 thetarget limb.

• History of prior endovascular or surgical procedure on the index limb within 30 daysprior to enrollment or planned within 30 days of the index procedure.

• Subject is pregnant or breastfeeding. (Female subjects of childbearing potentialmust be non-breastfeeding and have a negative pregnancy test ≤ 7 days before theprocedure.)

• 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 performendovascular 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/dLor >220 umol/L, or is on dialysis.

• Subject is participating in another research study involving an investigationalagent (pharmaceutical, biologic, or medical device) that has not reached the primaryendpoint.

• Subject has other medical, social or psychological problems that, in the opinion ofthe investigator, preclude them from receiving this treatment, and the studyrequirements and evaluations pre- and post-treatment.

• Subject experiencing ongoing cardiac problems that per the investigator judgmentwould not make the subject ideal per the procedure.

• Subject has evidence of intracranial or gastrointestinal bleeding within the past 3months.

Angiographic Exclusion Criteria

• Failure to treat clinically significant inflow lesions in the ipsilateral iliac,femoral, or P1-P2 segments of the popliteal arteries with <50% residual stenosiswith no serious angiographic complications (e.g., embolism or dissection) prior totreatment of the target lesion.

• Residual stenosis, and/or serious angiographic complications (e.g., embolism) priorto the investigational device usage.

• The use of adjunctive devices to treat the target lesion other than theinvestigative Auryon laser catheter and/or PTA devices, such as scoring balloons,drug-eluting balloons, re-entry devices, lithotripsy devices, or other atherectomydevices (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.

Observational Study Inclusion Criteria:

• Subjects intended to be treated with the Auryon Atherectomy System for de-novo,restenotic or ISR lesions of the infra-popliteal arteries.

• Subjects presenting with symptomatic PAD with claudication or CLI by RutherfordCategory 2 - 6 of the target limb.

• Age of subject is ≥ 18.

• Subject has been informed of the nature of the study, agrees to participate, and hassigned the approved study consent form.

Observational Study Exclusion Criteria:

• Subjects with any medical condition that would make him/her an inappropriatecandidate 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 potentialmust be non-breastfeeding and have a negative pregnancy test ≤ 7 days before theprocedure.)

• Subject is already enrolled in other investigational (interventional) studies thatwould interfere with study endpoints.