VasQ External Support for Arteriovenous Fistula

Exclusion Criteria

• •1. Patients with the planned index procedure being a revision surgery of an existing fistula.
• •2. Main study cohort: Target artery smaller than 2.5 mm or larger than 6 mm in inner diameter by preoperative ultrasound.
• •Supplementary study cohort: Target artery smaller than 2 mm or larger than 4.1 mm in inner diameter by preoperative ultrasound.
• •3. Main study cohort: Target vein smaller than 2.5 mm in inner diameter by preoperative ultrasound.
• •Supplementary study cohort: Target vein smaller than 2 mm in inner diameter by preoperative ultrasound.
• •4. Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on preoperative ultrasound. (Scan should include the area between the planned anastomosis site and the Axillary vein.)
• •5. Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.
• •6. Patients with central venous stenosis or obstruction on the side of surgery.
• •7. Depth of vein greater than 8 mm (on ultrasound) on side of surgery.
• •8. Known coagulation disorder.
• •9. Congestive heart failure NYHA class ≥ 3.
• •10. Prior steal on the side of surgery.
• •11. Known allergy to nitinol.
• •12. Life expectancy less than 30 months.
• •13. Patients expecting to undergo kidney transplant within 6 months of enrollment.
• •14. Women of child bearing age without documented current negative pregnancy test.
• •15. Inability to give consent and/or comply with the study follow up schedule.