Directional Versus Orbital Atherectomy Plaque Modification and Luminal Area Assessment of the Femoro-popliteal Artery Via Intravascular Ultrasound

Inclusion Criteria:

- Subject's age ≥ 18 years;

- Subject (or Legal Guardian if applicable) is willing and able to provide consent
before any study-specific test or procedure is performed, signs the consent form, and
agrees to attend all required follow-up visits.

- Chronic, symptomatic lower limb ischemia defined as Rutherford categories 1-4

- Target lesion(s) located in a superficial femoral or popliteal arteries

- Degree of stenosis ≥70% via Qualitative Comparative Analysis (QCA)

- Total Lesion Length ≥ 80 mm and ≤ 150 mm

- Reference Vessel ≥ 3.0 mm and <6.5mm

- Patent infrapopliteal artery, i.e., single vessel runoff or better with at least one
of three vessels patent (<50% stenosis) to the ankle or foot with no planned
intervention.

- Subject is an acceptable candidate for percutaneous intervention using the OAS or DAS
in accordance with their labeled indications and instructions for use

Exclusion Criteria:

- Subjects who have an:

- Previously stented target lesion/vessel.

- Subjects who have undergone prior surgery of the SFA/PA in the target limb to treat
atherosclerotic disease.

- Presence of aneurysm in the target vessel.

- Interventional treatment is intended for in-stent restenosis at the peripheral
vascular site.

- Target vessel with moderate or severe angulation (e.g., > 30°) or tortuosity at the
treatment segment, that precludes safe advancement of the atherectomy device.

- Pre-planned interventional treatment includes planned laser, brachytherapy or
atherectomy procedure other than OAS or DAS.

- Known hypersensitivity or contraindication to contrast dye that, in the opinion of the
investigator, cannot be adequately pre-medicated.

- Known hypersensitivity/allergy to antiplatelet, anticoagulant, thrombolytic
medications

- Platelet count <80,000 mm3 or >600,000 mm3 or history of bleeding diathesis.

- Patient has any known coagulation disorder, including hypercoagulability

- Receiving dialysis or immunosuppressant therapy.

- Patient has evidence of intracranial or gastrointestinal bleeding within last 3
months.

- Patient has history of severe trauma, fracture, major surgery or biopsy of a
parenchymal organ within past 14 days,

- Female patient who is pregnant or nursing a child,

- Current participation in another investigational drug or device clinical study that
has not completed the primary endpoint at the time of randomization/enrollment or that
clinically interferes with the current study endpoints.