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

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.