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ACTIVE NOT RECRUITING
NCT05418816
NA

SelfWrap-Assisted Arteriovenous Fistulas

Sponsor: VenoStent

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2021-06-14

Completion Date

2026-09

Last Updated

2025-04-01

Healthy Volunteers

No

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.

Locations (1)

Sanatorio Italiano

Asunción, Paraguay