JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions

Exclusion Criteria

• •1. Subject is unable to understand the study or has a history of non-compliance with medical advice.
• •2. Subject is unwilling or unable to sign the Informed Consent Form (ICF).
• •3. Subject is currently enrolled in another clinical investigational study that might clinically interfere with the current study endpoints (e.g., limit use of study-recommended medications, etc.).
• •4. Subject is pregnant or planning to become pregnant within the study period.
• •5. Subject has a known sensitivity to contrast media and the sensitivity cannot be adequately pre-medicated for.
• •6. Subject is diagnosed with chronic renal failure or has a creatinine level \> 2.5 mg/dl and is not on chronic dialysis.
• •7. Subject has a known allergy to heparin, ASA, Plavix.
• •8. Subject has a history of bleeding disorders or platelet count \< 80,000 cells/ml.
• •9. Subject experiences ongoing cardiac problems (e.g., cardiac arrhythmias, congestive heart failure exacerbation, myocardial infarction, etc.) that, per the investigator, would not make the subject an ideal candidate for study procedures.
• •10. Subject has a CVA or TIA within 4 weeks prior to JetStream procedure.
• •11. Subject has an anticipated life span of less than 6 months.
• •12. Subject is suspected of having an active systemic infection.
• •13. Subject per the investigator's medical judgment must be excluded from the study.
• •14. Limited vascular access that precludes safe advancement of the Jetstream NAVITUS System to the target lesion(s).
• •15. Patient has evidence of intracranial or gastrointestinal bleeding within the past 3 months.
• •16. Patient has had severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.
• •17. Patient has any planned surgical intervention or endovascular procedure within 15 days after the index procedure.
• •18. Use of another debulking device during the index procedure prior to the Jetstream NAVITUS System.
• •19. Use of another debulking device after the Jetstream NAVITUS system.
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