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SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study — SAVE-FistulaS  

Chronic Kidney Diseases Clinical Trial

Official title:
SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

Clinical Trial Summary

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.

Clinical Trial Description

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 200 participants from up to 20 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06001827
Study type Interventional
Source VenoStent
Contact Mark Barakat, MD
Phone (832) 429-5362
Email mark.barakat@venostent.com
Status Recruiting
Phase N/A
Start date November 20, 2023
Completion date December 2027
View Details
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