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.

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