Evaluation of the Pantheris Optical Coherence Tomography Imaging Atherectomy System for Use in the Peripheral Vasculature

The trial will enroll up to 173 subjects diagnosed with peripheral arterial disease of the
lower extremities at up to 20 sites (up to 3 international sites), including 133 Intention
to Treat subjects and up to 2 additional Roll-In subjects at each site (up to 40 Roll-In
subjects total). The primary disease must be located in reference vessel diameters ≥ 2.5 mm
and ≤ 7.0 mm. Trial success is focused on safety including rates of major adverse events
through 6 months as adjudicated by a Clinical Events Committee. Effectiveness will be
evaluated using technical success, defined as the percent of target lesions that have a
residual diameter stenosis <50% post-treatment with the Pantheris device alone as assessed
by Angiographic Core Lab.

Inclusion Criteria:

- Age ≥ 18 years old;

- Subject is a candidate for percutaneous intervention for peripheral arterial disease
in the legs;

- Subject is willing and able to give informed consent;

- Documented symptomatic atherosclerotic peripheral arterial disease Rutherford
Classification 2-5;

- Reference vessel lumen proximal to target lesion ≥ 2.5 mm and ≤ 7.0 mm in diameter by
visual estimation;

- Subject has de novo target lesion(s) with stenosis >70% by visual estimation distal
to the profunda femoral artery. No more than 2 lesions may be treated with the
Pantheris device;

- Target lesion length ≤ 15 cm (may be two tandem lesions that do not exceed 15cm in
total length);

- Subject is capable of meeting requirements and be present at the follow-up clinic
visits at 30 days and 6 months;

- At least one patent tibial run-off vessel at baseline.

Exclusion Criteria:

- Subject is pregnant or breast feeding;

- Rutherford Class 0 to 1 (asymptomatic and mild claudication);

- Rutherford Class 6 (critical limb ischemia);

- Moderate to severe calcification of the target lesion;

- Acute ischemia and/or acute thrombosis of the SFA-Popliteal segment;

- In-stent restenosis within the target lesion;

- Target lesion with any type of stent or graft;

- Target lesion in the iliac artery;

- Target lesion stenosis <70%;

- Subjects with significant (≥70%) occlusive lesions proximal to the target lesion not
successfully treated during the index procedure (upstream disease) and prior to
treatment of the target lesion;

- Endovascular or surgical procedure performed on the index limb less than or equal to
30 days prior to the index procedure;

- Planned endovascular or surgical procedure 30 days after the index procedure;

- Lesion in the contralateral limb requiring intervention during the index procedure or
within 30 days of the index procedure;

- Subjects with active systemic infections whether they are being currently treated or
not;

- Subjects on chronic hemodialysis or creatinine level >2.0mg/dL;

- Evidence or history of intracranial or gastrointestinal bleeding, intracranial
aneurysm, myocardial infarction or stroke within the past 2 months;

- Evidence or history of aneurysmal target vessel within the past 2 months;

- History of severe trauma, fracture, major surgery or biopsy of a parenchymal organ
within the past 14 days;

- Known allergy to contrast agents or medications used to perform endovascular
intervention that cannot be adequately pre-treated;

- Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is
contraindicated;

- History of heparin-induced thrombocytopenia (HIT);

- Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with
platelet count less than 100,000/mm2, known coagulopathy, or INR >1.5;

- Any thrombolytic therapy within 2 weeks of the index procedure;

- Any clinical and/or angiographic complication attributed to the use of another device
prior to the insertion of the study device into the subject;

- Subjects or their legal guardians who have not or will not sign the Informed Consent;

- Subjects who are unwilling or unable to comply with the follow-up study requirements;

- Participation in any study of an investigational device, medication, biologic or
other agent within 30 days prior to enrollment that is either a cardiovascular study
or could, in the judgment of the investigator, affect the results of the study.