SelfWrap-Assisted Arteriovenous Fistulas

Exclusion Criteria

• •1. Planned index procedure to revise or repair an existing fistula;
• •2. Twelve months or longer with a catheter, on the planned side of AVF creation; or if there has been any previously failed AVF and AVG on the planned side of AVF creation.
• •3. Significant (\> 50%) stenosis at the target vein on the side of surgery, as diagnosed by preoperative ultrasound;
• •4. Known central venous stenosis \> 50%;
• •5. Amputated limb;
• •6. Use of a peripherally-inserted central catheter (PICC) line;
• •7. Abnormal cardiac rhythm;
• •8. Known coagulation disorder;
• •9. Known or suspected active infection at the time of surgery;
• •10. Congestive heart failure NYHA class 4;
• •11. Prior steal on the side of surgery;
• •12. Enrolled in another investigational drug, device, or biological study and has not completed the primary endpoint(s), or was previously enrolled in this study;
• •13. Life expectancy less than 12 months;
• •14. Patient expecting to undergo kidney transplant surgery within 12 months of enrollment;
• •15. Patient has a comorbid condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol or confound data interpretation.
• •16. Unwillingness or inability to give consent and/or comply with the study follow up schedule.