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Recruiting NCT06001827

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

No phase Interventional Chronic Kidney Diseases End Stage Renal Disease Arteriovenous Fistula Hemodialysis Access Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SelfWrap Bioabsorbable Perivascular Wrap, Untreated AVF Control.
Who it may be relevant to
Registry conditions: Chronic Kidney Diseases, End Stage Renal Disease, Arteriovenous Fistula, Hemodialysis Access Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

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

Primary outcome measures

  • Unassisted Maturation by 180 days [Time frame: Assessed at up to 6 months]
  • Freedom from access-related adverse events through 30 days [Time frame: Assessed through 30 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 28 centers
  • 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
  • Orange County Vascular Access Center — Garden Grove
  • Tallahassee Research Institute — Tallahassee
  • Lutheran Medical Group — Fort Wayne
  • Surgical Associates of Lexington — Lexington
  • … and 20 more centers

Identifiers

NCT: NCT06001827 · VENO-CIP002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗