A Non-Randomized Study of the NightHawk Peripheral Plaque Excision System During Plaque Excision of Peripheral Arterial Disease

Inclusion Criteria: 1. Patient requires treatment for peripheral arterial disease (PAD). 2. Patient is willing and able to provide Informed Consent. 3. Patient has at least one focal, de novo infrainguinal lesion in a native vessel. 4. The minimum reference vessel diameter is 2.0 - 4.5 mm, dependent on the NightHawk device used. 5. The lesion is ≥ 50% stenosed by quantitative vascular angiography. 6. The lesion is ≤ 7 cm in length. 7. The patient must be able to take at least one form of anti-platelet or anti-thrombotic therapy. Exclusion Criteria: 1. Patient presents with degree of limb disease or a co-existing medical condition that makes revascularization inappropriate. 2. The patient has diffuse peripheral arterial disease and/or the disease is heavily calcified. 3. Patient presents with concomitant disease contraindicating an endovascular intervention. 4. Patient is pregnant. 5. The patient has a hypersensitivity to contrast materials that cannot be adequately pretreated.