NCT06001827

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: VenoStent · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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.

Conditions

• Chronic Kidney Diseases
• End Stage Renal Disease
• Arteriovenous Fistula
• Hemodialysis Access Failure
• ESRD
• Vascular Access Complication
• Renal Failure
• Catheter Complications
• Catheter Dysfunction
• Renal Insufficiency

Interventions

Type	Name	Description
DEVICE	SelfWrap Bioabsorbable Perivascular Wrap	SelfWrap is applied during arteriovenous fistula (AVF) creation surgery. It provides mechanical support to improve maturation and patency of AVFs.
PROCEDURE	Untreated AVF Control	AVF creation surgery without any intervention

Timeline

• Start date: 2024-01-03
• Primary completion: 2027-06-01
• Completion: 2029-12-01
• First posted: 2023-08-21
• Last updated: 2026-02-17

Locations

28 sites across 1 country: United States

Regulatory

• FDA-regulated device study