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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2024-01-03 |
| Est. Completion | 2029-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06001827
The ClinicalTrials.gov registry entry for NCT06001827 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 826-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (27% lower). The listed sponsor is VenoStent, which has 1 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.
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