VasQ is an external support implant for arteriovenous fistulas created for dialysis access.
This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms:
* Treatment arm: End to side fistula supported with VasQ * Control: Standard of care end to side fistula
Patients who are candidates for the creation of a new radiocephalic or brachiocephalic end-to-side surgical AV fistula for dialysis access (per VasQ IFU and investigator clinical judgment) and consent to take part in the study.
Male and non-pregnant female participants.
Age 18-80 years
Patients willing and able (physically and geographically) to attend follow up visits over a period of 12 months.
Index procedure being a revision surgery of an existing fistula.
Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on preoperative ultrasound. (Scan should include the full length of the expected fistula outflow, starting at the planned anastomosis site)
Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.
Known central venous stenosis or obstruction on the side of surgery.