This is a single-center, prospective, single-arm clinical study to evaluate the feasibility, safety, and performance of VenoStent's SelfWrap® Bioabsorbable Perivascular Wrap on arteriovenous fistulas (AVFs). All participants are chronic kidney disease (CKD) patients already receiving hemodialysis treatments that are referred for creation of a new arteriovenous fistula (AVF).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years, male or female;
✓. Subjects already receiving hemodialysis treatments that are ultimately referred for a new AVF, per current US KDOQI Clinical Practice Guidelines for Vascular Access updated in 2019 which recommend an AVF or arteriovenous graft (AVG) consistent with patient life-plan, overall goals of care, and anticipated duration of hemodialysis; if life expectancy \> 1 year, recommend forearm AVF, forearm AVG, or upper arm AVF; if \< 1 year, recommend forearm AVG/upper arm AVG; if urgent start, early cannulation AVG or central venous catheter (CVC);
✓. Target cephalic vein inner diameter ≥ 2.5 mm and target artery ≥ 2.0 mm as measured via duplex ultrasound with a tourniquet applied;
✓. For radial AVFs, a nonpathological modified Allen test;
✓. Triphasic arterial flow and intact venous outflow;
✓. A vascular access site being used for hemodialysis that is either positioned contralateral to the planned AVF creation surgery or located in the groin. If the catheter is positioned on the same side as the planned AVF, the catheter will be moved to the other arm prior to the AVF created surgery.
✓. Participant is willing and able to comply with study requirements and sign an informed consent.
Exclusion criteria
✕. Planned index procedure to revise or repair an existing fistula;
✕. Twelve months or longer with a catheter, on the planned side of AVF creation; or if there has been any previously failed AVF and AVG on the planned side of AVF creation.