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SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
NCT06001827 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VenoStent, which has 29 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Chronic Kidney Diseases appearing as the primary indexed condition, and to 2 interventions — of which SelfWrap Bioabsorbable Perivascular Wrap is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06001827 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Arizona, South Carolina, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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: Chronic Kidney Diseases, End Stage Renal Disease, Renal Insufficiency, Renal Failure, ESRD. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06001827?
The interventions under investigation include: SelfWrap Bioabsorbable Perivascular Wrap (DEVICE), Untreated AVF Control (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06001827?
This trial is sponsored by VenoStent, which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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