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SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

NCT06001827 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-02-17

No results posted yet for this study

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.

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

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

Sponsors & Collaborators

  • VenoStent

    lead INDUSTRY

Principal Investigators

  • Timothy Boire, PhD · VenoStent, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-03
Primary Completion
2027-06-30
Completion
2029-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06001827 on ClinicalTrials.gov