Designed to make Arteriovenous (AV) Access Surgery work the first time
This means more procedures, more time on a central venous catheter, and a host of other complications. VenoStent’s bioabsorbable implant, SelfWrap,2 is being studied to help veins “behave” more like arteries and make the surgery work the first time.
1 Number of AV access surgeries is estimated based on the number of incident hemodialysis patients (which require AV access creation), plus the number of incident and prevalent hemodialysis patients that experience AV access abandonment on an annual basis (Lee et al., 2019, JASN, 30: 2209-2218, doi:10.1681/ASN.2019030318 and Al-Jaishi et al., 2014, Am J Kidney Disease, 63(3): 464-478, doi:10.1053/j.ajkd.2013.08.023 ) and would require another AV access to be created.
2 SelfWrap is for investigational use only.
VenoStent’s SAVE-FistulaS clinical trial is enrolling 200 participants
You may be eligible to participate in the SAVE-FistulaS trial, the first ever randomized, controlled clinical trial in the United States to evaluate a medical device for improving arteriovenous fistula (AVF) creation outcomes, if you are:
- A person with chronic kidney disease (CKD)
- At least 18 years of age
- Referred for creation of a new arteriovenous fistula
- Willing and able to comply with study requirements, communicate with the study team, and attend follow up visits over a period of 36 months
If you are interested in participating, please visit savefistulas.org or clinicaltrials.gov to see if there is an investigator in your area and reach out directly to the Study Coordinator at the Center nearest you. If there is no center near you, please be sure to check back periodically, as additional investigators will be added in other areas of the country over the next several months in 2024. Please email clinical.affairs@venostent.com if you have further questions.
The first ever Randomized, Controlled Trial (RCT) in the United States to evaluate a medical device to improve Arteriovenous Fistula creation outcomes
The SAVE-FistulaS trial is a multi-center, prospective, randomized, double-arm, single-blind, evaluator-blinded clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF). This study will involve approximately 200 participants from up to 20 investigational sites, randomized 1:1 for treatment with the SelfWrap or the untreated AVF control (i.e. standard of care). Participants will be followed for a duration of 36 months.
SelfWrap is currently in the research and development phase and is not available for sale in any country. Investigational Device. Limited by Federal Law to Investigational Use.