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

• 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.