IN.PACT™ AV Access IDE Study

Exclusion Criteria

• •1. Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children
• •2. Patient is receiving immunosuppressive therapy
• •3. Patient is anticipating a kidney transplant within 6 months of enrollment into the study
• •4. Patient has undergone prior intervention of access site within 30 days of index procedure
• •5. Patient with anticipated conversion to peritoneal dialysis
• •6. Patient has an infected AV access or systemic infection
• •7. Patient has planned surgical revision of access site
• •8. Patient with secondary non-target lesion requiring treatment within 30-days post index procedure
• •9. Patient with hemodynamically significant central venous stenoses that cannot be successfully treated prior to treatment of the target lesion
• •10. Patient with target AVF or access circuit which previously had or currently has a thrombosis
• •11. Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system
• •12. Patient with target lesion located central to the axillosubclavian junction
• •13. Patient has significant arterial inflow lesion requiring treatment more than 2 cm upstream from the anastomosis in the AV access
• •14. Patient has presence of pseudoaneurysm or aneurysm requiring treatment at the lesion site
• •15. Patient has presence of a stent located in the target AV access circuit
• •16. Patients with known allergies or sensitivities to paclitaxel
• •17. Patient with known contraindication, including allergic reaction, or sensitivity to contrast material that cannot be adequately pre-treated
• •18. Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy
• •19. Patient with clinically significant Steal Syndrome requiring treatment
• •20. Patient is enrolled in another investigational drug, device, or biological study and has not completed the primary endpoint, or was previously enrolled in this study
• •21. Patient has a comorbid-condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol of confound data interpretation