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SelfWrap-Assisted Arteriovenous Fistulas

NCT05418816 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-04-01

No results posted yet for this study

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).

Conditions

  • Chronic Kidney Diseases
  • Chronic Kidney Failure
  • End Stage Renal Disease
  • End Stage Kidney Disease
  • Arteriovenous Fistula
  • Hemodialysis Access Failure
  • Catheter Complications
  • Catheter Dysfunction
  • Vascular Diseases
  • Arteriovenous Malformations
  • Vascular Malformations
  • Vascular Fistula
  • Fistula
  • Renal Insufficiency
  • Renal Failure
  • Renal Failure Chronic
  • Urologic Diseases

Interventions

DEVICE

SelfWrap Bioabsorbable Perivascular Wrap

SelfWrap is applied during the normal arteriovenous fistula (AVF) creation procedure. It provides mechanical support to the vein and induces outward remodeling to improve maturation and patency of AVFs.

Sponsors & Collaborators

  • VenoStent

    lead INDUSTRY

Principal Investigators

  • Adrian Ebner, MD · Sanatorio Italiano

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-14
Primary Completion
2022-02-23
Completion
2026-09-30
FDA Device
Yes

Countries

  • Paraguay

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05418816 on ClinicalTrials.gov