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ACTIVE_NOT_RECRUITINGNA

SelfWrap-Assisted Arteriovenous Fistulas

Initial Feasibility Study of SelfWrap-Assisted Arteriovenous Fistulas (SW-AVF)

NCT05418816•VenoStent

Summary

This is a single-center, prospective, single-arm clinical study to evaluate the feasibility, safety, and performance of VenoStent's SelfWrap® Bioabsorbable Perivascular Wrap on arteriovenous fistulas (AVFs). All participants are chronic kidney disease (CKD) patients already receiving hemodialysis treatments that are referred for creation of a new arteriovenous fistula (AVF).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years, male or female;
•2. Subjects already receiving hemodialysis treatments that are ultimately referred for a new AVF, per current US KDOQI Clinical Practice Guidelines for Vascular Access updated in 2019 which recommend an AVF or arteriovenous graft (AVG) consistent with patient life-plan, overall goals of care, and anticipated duration of hemodialysis; if life expectancy \> 1 year, recommend forearm AVF, forearm AVG, or upper arm AVF; if \< 1 year, recommend forearm AVG/upper arm AVG; if urgent start, early cannulation AVG or central venous catheter (CVC);
•3. Target cephalic vein inner diameter ≥ 2.5 mm and target artery ≥ 2.0 mm as measured via duplex ultrasound with a tourniquet applied;
•4. For radial AVFs, a nonpathological modified Allen test;
•5. Triphasic arterial flow and intact venous outflow;
•6. A vascular access site being used for hemodialysis that is either positioned contralateral to the planned AVF creation surgery or located in the groin. If the catheter is positioned on the same side as the planned AVF, the catheter will be moved to the other arm prior to the AVF created surgery.
•7. Participant is willing and able to comply with study requirements and sign an informed consent.

Exclusion Criteria

•1. Planned index procedure to revise or repair an existing fistula;
•2. Twelve months or longer with a catheter, on the planned side of AVF creation; or if there has been any previously failed AVF and AVG on the planned side of AVF creation.
•3. Significant (\> 50%) stenosis at the target vein on the side of surgery, as diagnosed by preoperative ultrasound;
•4. Known central venous stenosis \> 50%;
•5. Amputated limb;
•6. Use of a peripherally-inserted central catheter (PICC) line;
•7. Abnormal cardiac rhythm;
•8. Known coagulation disorder;
•9. Known or suspected active infection at the time of surgery;
•10. Congestive heart failure NYHA class 4;
+6 more criteria

Locations (1)

Sanatorio Italiano

Asunción, Paraguay

Key Dates

Start Date

June 14, 2021

Primary Completion Date

February 23, 2022

Completion Date

September 1, 2026

Last Updated

April 1, 2025

Enrollment

ACTUAL participants

Conditions

Chronic Kidney DiseasesChronic Kidney FailureEnd Stage Renal DiseaseEnd Stage Kidney DiseaseArteriovenous FistulaHemodialysis Access FailureCatheter ComplicationsCatheter DysfunctionVascular DiseasesArteriovenous MalformationsVascular MalformationsVascular FistulaFistulaRenal InsufficiencyRenal FailureRenal Failure ChronicUrologic Diseases

Interventions

SelfWrap Bioabsorbable Perivascular Wrap

DEVICE

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RECRUITINGNA

Handgrip Exercise Training and CKD

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SelfWrap-Assisted Arteriovenous Fistulas

Inclusion Criteria

Exclusion Criteria

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