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NCT06001827 · ClinicalTrials.gov registry record · NA

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

A NA study of End Stage Renal Disease and Chronic Kidney Diseases, sponsored by VenoStent.

Recruiting
Registry status
NA
Development phase
600
Enrollment target
20
Study locations

NCT06001827: Recruiting NA study of End Stage Renal Disease and Chronic Kidney Diseases, sponsored by VenoStent.

NCT06001827 is a NA study of End Stage Renal Disease and Chronic Kidney Diseases that is actively recruiting participants, run by VenoStent. The registered enrollment target is 600 participants, below the 826-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (27% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06001827, a NA study of End Stage Renal Disease and Chronic Kidney Diseases, is actively recruiting participants, sponsored by VenoStent.

RECRUITING
Registry status
NA
Development phase
600 participants
Enrollment target
20
Study locations

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.

Primary Outcome

A participant who is either 1) on hemodialysis on or before day 150 and the AVF has been cannulated with two needles for at least 75% of dialysis sessions within any 4 consecutive week period to achieve the prescribed dialysis by the 180 day follow up, and did not require any facilitative endovascular or surgical intervention to achieve this, or 2) is not on hemodialysis on or before day 150, but ultrasound measurements by the 180 day follow up indicate a proximal arterial flow rate of at least

Conditions Studied

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

Interventions

  • DEVICE SelfWrap Bioabsorbable Perivascular Wrap
  • PROCEDURE Untreated AVF Control

Study Locations (20)

Arizona

  • AKDHC Bullhead City - Bullhead City
  • AKDHC Marana Surgery Center - Marana
  • Arizona Kidney Disease & Hypertension Centers (AKDHC) Phoenix Surgery Center - Phoenix
  • Banner University Medical Center - Tucson

South Carolina

  • MUSC Charleston - Charleston
  • Vascular Care of South Carolina - Columbia
  • MUSC Black River - Florence
  • Prisma Health - Greenville

Missouri

  • University of Missouri - Columbia
  • Saint Louis University - St Louis
  • Washington University School of Medicine - St Louis

North Carolina

  • Surgical Specialists of Charlotte, P.A. - Charlotte
  • WakeMed - Raleigh

California

  • Orange County Vascular Access Center - Garden Grove

Florida

  • Tallahassee Research Institute - Tallahassee

Indiana

  • Lutheran Medical Group - Fort Wayne

Kentucky

  • Surgical Associates of Lexington - Lexington

Trial Details

FieldValue
Enrollment Target 600 participants
Start Date 2024-01-03
Est. Completion 2029-12
Phase NA
VenoStent

1 total trials

What NCT06001827 shows while recruiting

NCT06001827 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, below the 826-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (27% lower).

The record links to 10 conditions, with End Stage Renal Disease appearing as the primary indexed condition, and to 2 interventions - of which SelfWrap Bioabsorbable Perivascular Wrap is the first listed.

NCT06001827 names 20 study sites across 11 states, led by Arizona, South Carolina, Missouri.

Frequently Asked Questions

What is clinical trial NCT06001827 about?

NCT06001827 is a clinical study titled "SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas 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.

What is the current status of trial NCT06001827?

This trial is currently recruiting. It is a NA study. The enrollment target is 600 participants. The study started on 2024-01-03. Estimated completion is 2029-12.

What conditions does trial NCT06001827 study?

This clinical trial studies the following conditions: End Stage Renal Disease, Chronic Kidney Diseases, Renal Insufficiency, ESRD, Renal Failure.

What interventions are being tested in trial NCT06001827?

The interventions under investigation include: SelfWrap Bioabsorbable Perivascular Wrap (DEVICE), Untreated AVF Control (PROCEDURE).

Who is sponsoring clinical trial NCT06001827?

This trial is sponsored by VenoStent, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06001827 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for End Stage Renal Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06001827's enrollment target sits among peer trials

600 9th of 86 higher than 78 of 86 other End Stage Renal Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other End Stage Renal Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06001827

Source: ClinicalTrials.gov NCT06001827, the US trial registry maintained by the National Library of Medicine. NCT06001827 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.