RecruitingChronic Kidney DiseasesEnd Stage Renal DiseaseArteriovenous Fistula

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

Eligible age

18+ yrs

Accepts

All genders

Locations

13 states

Healthy volunteers

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About this study

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.

Sponsor: VenoStent

You may qualify if…

✓ 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

You may not qualify if…

✕ 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 least 50%) stenosis at the target vein on the side of surgery (between the planned anastomosis site and the axillary vein), as diagnosed by preoperative ultrasound
✕ Known central venous stenosis of at least 50% on the side of surgery
✕ Presence of a stent or a stent graft within the access circuit
✕ Known or suspected coagulation disorder that, in the opinion of the Investigator, puts too much risk on the patient for AVF creation
✕ Known or suspected active infection at the time of surgery