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 protrusion into the lumen is noted on angiography in two orthogonal views; * Subjects on chronic hemodialysis or creatinine level \>2.5 mg/dL; * CVA or stroke within 60 days prior to the index procedure; * 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; * Known allergy to contrast agents or medications used to perform endovascular * intervention that cannot be adequately pre-treated; * Subjects in whom anti-platelet, aspirin, anticoagulant, or thrombolytic therapy is contraindicated; * 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 during the index procedure; * 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; or * 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.