VenoStent
This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap.
This is a multi-center, prospective, randomized, double-arm, single-blind, evaluator-blinded clinical trial for CKD patients referred for creation of a new arteriovenous fistula (AVF). This study will involve approximately 600 participants from up to 30 investigational sites, randomized 1:1 to treatment with the SelfWrap or the untreated AVF control (i.e. standard of care, SOC). Participants will be followed for a duration of 36 months.
Inclusion Criteria: * Age of at least 18 years * Referred for creation of a new AVF * Willing and able to comply with study requirements, communicate with the study team, and attend follow up visits over a period of 36 months Exclusion Criteria: * Planned index procedure to revise or repair an existing fistula * Target artery inner diameter \< 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia * Target vein inner diameter \< 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia * Significant (at lea…
SelfWrap is applied during arteriovenous fistula (AVF) creation surgery. It provides mechanical support to improve maturation and patency of AVFs.
AVF creation surgery without any intervention