SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study (SAVE-FistulaS)

February 12, 2026 updated by: VenoStent
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Bullhead City, Arizona, United States, 86442
        • Recruiting
        • AKDHC Bullhead City
        • Contact:
        • Principal Investigator:
          • Rick Mishler, MD
      • Marana, Arizona, United States, 85658
        • Recruiting
        • AKDHC Marana Surgery Center
        • Principal Investigator:
          • Zhongguang (Ziggy) Yang, MD, PhD
        • Contact:
      • Phoenix, Arizona, United States, 85012
        • Recruiting
        • Arizona Kidney Disease & Hypertension Centers (AKDHC) Phoenix Surgery Center
        • Principal Investigator:
          • Shouwen Wang, MD, PhD
        • Contact:
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • Banner University Medical Center
        • Principal Investigator:
          • Wei Zhou, MD
        • Contact:
    • California
      • Garden Grove, California, United States, 92840
        • Recruiting
        • Orange County Vascular Access Center
        • Contact:
        • Principal Investigator:
          • Steven Posner, MD
    • Florida
      • Tallahassee, Florida, United States, 32308
        • Recruiting
        • Tallahassee Research Institute
        • Contact:
        • Principal Investigator:
          • Andres Vargas, MD
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Recruiting
        • Lutheran Medical Group
        • Contact:
        • Principal Investigator:
          • Vincent Scavo, MD
        • Contact:
          • Sharon Eichman
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Surgical Associates of Lexington
        • Principal Investigator:
          • Colby Atkins, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Randall DeMartino, MD
        • Contact:
    • Missouri
      • Columbia, Missouri, United States, 65212
      • St Louis, Missouri, United States, 63110
      • St Louis, Missouri, United States, 63104
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health
        • Principal Investigator:
          • Yana Etkin, MD
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28226
        • Recruiting
        • Surgical Specialists of Charlotte, P.A.
        • Principal Investigator:
          • Jason Burgess, MD
        • Contact:
        • Contact:
      • Raleigh, North Carolina, United States, 27610
        • Recruiting
        • WakeMed
        • Contact:
        • Contact:
          • Rhonda Norton
        • Principal Investigator:
          • Kirk Charles, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • MUSC Charleston
        • Contact:
        • Principal Investigator:
          • Adam Tanious, MD
      • Columbia, South Carolina, United States, 29203
        • Recruiting
        • Vascular Care of South Carolina
        • Principal Investigator:
          • Dion Franga, MD
        • Contact:
      • Florence, South Carolina, United States, 29505
        • Recruiting
        • MUSC Black River
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cary Brewton, DO
      • Greenville, South Carolina, United States, 29615
      • Orangeburg, South Carolina, United States, 29118
        • Recruiting
        • Medical University of South Carolina (MUSC) Orangeburg / Dialysis Access Institute
        • Principal Investigator:
          • Mark London, MD
        • Contact:
        • Contact:
      • Spartanburg, South Carolina, United States, 29650
        • Recruiting
        • Spartanburg Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Ari Kramer, MD
        • Contact:
    • Tennessee
      • Memphis, Tennessee, United States, 38115
        • Recruiting
        • James Eric Gardner, MD, PC
        • Contact:
        • Principal Investigator:
          • James E Gardner, MD
    • Texas
      • Austin, Texas, United States, 78701
        • Recruiting
        • Saint David's HealthCare Partnership, L.P., LLP
        • Principal Investigator:
          • Ryan Turley, MD
        • Contact:
      • El Paso, Texas, United States, 79912
        • Recruiting
        • A&V Doctors PLLC
        • Contact:
        • Principal Investigator:
          • Emmanuel Anekwe, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Research Institute
        • Principal Investigator:
          • Eric Peden, MD
        • Contact:
      • Mission, Texas, United States, 78572
        • Recruiting
        • Upper Valley Dialysis Access Center, LLC
        • Contact:
        • Principal Investigator:
          • Chijoke Ogbu, MD
      • Sugar Land, Texas, United States, 77479
        • Recruiting
        • Houston Methodist Research Institute (Sugar Land)
        • Principal Investigator:
          • Eric Peden, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age of at least 18 years
  • Referred for creation of a new AVF
  • Willing and able to comply with study requirements, communicate with the study team, and attend follow up visits over a period of 36 months

Exclusion Criteria:

  • Planned index procedure to revise or repair an existing fistula
  • Target artery inner diameter < 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia
  • Target vein inner diameter < 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia
  • Significant (at least 50%) stenosis at the target vein on the side of surgery (between the planned anastomosis site and the axillary vein), as diagnosed by preoperative ultrasound
  • Known central venous stenosis of at least 50% on the side of surgery
  • Presence of a stent or a stent graft within the access circuit
  • Known or suspected coagulation disorder that, in the opinion of the Investigator, puts too much risk on the patient for AVF creation
  • Known or suspected active infection at the time of surgery
  • Congestive heart failure NYHA class 4
  • Prior steal on the side of surgery;
  • Enrolled in another investigational drug, device, or biological study, or was previously enrolled in this study
  • Life expectancy less than 12 months
  • Expected to undergo kidney transplant surgery within 6 months of enrollment
  • Expected to undergo home hemodialysis
  • Females of childbearing potential (premenopausal and not surgically sterile) without documented current negative pregnancy test at screening
  • Presence of a comorbid condition that, in the opinion of the Investigator, may significantly confound the collection of safety and efficacy data in this study
  • Unwillingness or inability to give consent and/or comply with the study follow up schedule
  • Any health condition, which in the opinion of the Investigator, would interfere with the safety of the participant or the participant's ability to comply with the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery
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.
Other Names:
  • SelfWrap
Sham Comparator: Control Arm
AVF creation surgery without any intervention (untreated AVF control, or standard of care)
Procedure: Untreated AVF Control
AVF creation surgery without any intervention
Other Names:
  • Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unassisted Maturation by 180 days
Time Frame: Assessed at up to 6 months
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 500 mL/min and a vein inner diameter of at least 5.0 mm at 5 - 8 cm from the anastomosis, and did not require any facilitative endovascular or surgical intervention through the 180 day follow up.
Assessed at up to 6 months
Freedom from access-related adverse events through 30 days
Time Frame: Assessed through 30 days
Freedom from access-related adverse events through 30 days
Assessed through 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VenoStent

Investigators

  • Study Director: Timothy Boire, PhD, VenoStent, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

August 14, 2023

First Submitted That Met QC Criteria

August 14, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VENO-CIP002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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