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.
Parallel
VasQ
DeviceExternal support implant for the arteriovenous fistula
Arteriovenous fistula creation for dialysis vascular access
Procedure/SurgeryEnd to side fistula creation in the arm for dialysis vascular access
Fistula functional success
The time, in days, to the first day of a 28-day period in which the study fistula was able to be cannulated with two dialysis needles for at least 75% of dialysis sessions to achieve the prescribed dialysis
Safety - vascular access related complications
Comparable rate of access related complications (including major reintervention and cannulation related complications)
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