A Multi Center, Study to Evaluate the Safety and Efficacy of the VasQ External Support Device for Arteriovenous Fistulas

A Prospective, Multi Center, Study to Evaluate the Safety and Efficacy of the VasQ External Support Device for Brachiocephalic Arteriovenous Fistula

This study is a prospective, multi center, randomized, controlled study of the VasQ in arteriovenous fistulas. The VasQ constraints and directs the geometrical parameters of the fistula as well as the vascular diameter and gradient in the vicinity of the AV shunt. These geometrical constraints direct flow and influence hemodynamics, and hence minimize turbulence and promote laminar flow. The device is designed to improve short term maturation and long term patency of the fistula. The VasQ is a permanent implant intended for use as a subcutaneous arteriovenous conduit support for vascular access.

Inclusion Criteria:

• Patients referred for creation of a new brachiocephalic fistula who consent to take part in the study.
• Aged > 18
• Male and female participants
• Patients willing and able to attend follow up visits over a period of 6 months

Exclusion Criteria:

• Patients who require revision surgery.
• Having had previous arteriovenous fistula surgery is not a contraindication to recruitment provided the new procedure is not revision surgery
• Target arteries smaller than 3 mm in diameter
• Target vein smaller than 3 mm in diameter
• Stenotic veins on the side of surgery as diagnosed on pre-op ultrasound
• Patients with prior central venous stenosis or obstruction on the side of surgery
• Depth of vein greater than 8 mm (on US) on side of surgery
• Known coagulation disorder
• Prior steal
• Known allergy to nitinol
• Life expectancy less than 6 months
• Inability to give consent and/or comply with the study follow up schedule
• Women of child bearing age