VasQ External Support for Arteriovenous Fistula

Inclusion criteria

• Main study cohort: Patients referred for creation of a new brachiocephalic fistula who consent to take part in the study and which are not indicated for a more distal fistula per treatment guidelines.

Supplementary study cohort: Patients referred for creation of a new forearm fistula who consent to take part in the study.

• Male and female participants.
• Age 18-80 years.
• Patients willing and able to attend follow up visits over a period of 24 months.

Exclusion criteria

• Patients with the planned index procedure being a revision surgery of an existing fistula.
• 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.

• 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.

• 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.)
• Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.
• Patients with central venous stenosis or obstruction on the side of surgery.
• Depth of vein greater than 8 mm (on ultrasound) on side of surgery.
• Known coagulation disorder.
• Congestive heart failure NYHA class ≥ 3.
• Prior steal on the side of surgery.
• Known allergy to nitinol.
• Life expectancy less than 30 months.
• Patients expecting to undergo kidney transplant within 6 months of enrollment.
• Women of child bearing age without documented current negative pregnancy test.
• Inability to give consent and/or comply with the study follow up schedule.