Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal

This study is a prospective, single-arm (non-randomized), post-market study which will
enroll up to 25 subjects. IVUS imaging and angiography will be used to assess procedural
outcomes in patients who have symptomatic peripheral artery disease who are treated with the
Sponsor's OAS and adjunctive balloon angioplasty. An independent IVUS Core Lab will be used
to provide adjudicated analyses for IVUS outcomes. In clinic follow-up visits will be
performed to one year (2 weeks, 6 months, 12 months).

Inclusion Criteria:

- Subject's age ≥ 18 years

- Subject is an acceptable candidate for percutaneous intervention using the Sponsor's
OAS in accordance with its labeled indications and instructions for use

- Target lesion(s) located in a superficial femoral artery (SFA), popliteal (POP) or
tibioperoneal trunk (TPT)

- Tight lesions (>70% stenosis)

- Lesions less than 110 mm in length

- Artery with the vessel < 6.5 mm in diameter

- Subject is willing and able to sign an approved informed consent form

- Subject is willing and able to attend follow-up visits

Exclusion Criteria:

- Uncontrolled allergy to nitinol, stainless-steel or other stent materials or to
contrast agent

- Unable to take appropriate antiplatelet therapy

- Subject has no distal run-off

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

- Subject has history of coagulopathy or hypercoagulable disorder, is undergoing
hemodialysis or has impaired renal function (Cr > 2.5 mg/dl) at the time of treatment

- Female subject who is pregnant or nursing a child

- Intended interventional treatment includes planned laser, brachytherapy or
atherectomy procedure other than the Sponsor's OAS