Pantheris Atherectomy Treatment of In-Stent Restenosis In Lower Extremity Arteries

Inclusion Criteria: * Subject is \>18 years old; * Subject is willing and able to give informed consent; * Subject has Rutherford Classification of I-V; * Subject presenting with a single Class I, II or III ISR lesion as per Tosaka's Classification criteria in the lower leg extremities; * Target lesion must be \>70% stenosed and within a stented segment by angiographic visual estimation; * Reference vessel lumen acceptable for treatment with Pantheris catheter size as per visual angiographic estimation; * Target lesions must be within the stented segment and no more than 3 cm past the proximal or distal portions of the stent; * Target lesion is ≤30 cm in length; * Intraluminal crossing of totally occluded lesions prior to atherectomy; * At least one patent tibial run-off vessel at baseline; and * Subject is capable of meeting requirements and be present at the follow-up clinic visits at 30 days, 6 months and 12 months. Exclusion Criteria: * Subject is pregnant or breast feeding; * Rutherford Class 0 or VI; * Severe calcification of the target lesion; * Acute ischemia and/or acute thrombosis of the target lesion segment; * Target lesion with a covered stent; * Target lesion in the iliac artery; * Target lesion stenosis \<70%; * Target lesion \>30 cm in length; * Subjects with totally occluded stented segments that are not successfully crossed intraluminally prior to atherectomy treatment; * Grade 4 or 5 stent fracture affecting target stent, or where evidence of stent protr…