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Endovascular vs Surgical Arteriovenous Fistula Outcomes

NCT04404985 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-01-05

No results posted yet for this study

Summary

Arteriovenous fistulas (AVFs) are the preferred type of vascular access for dialysis, but many of them fail to mature. There are two techniques of creating AVFs either the traditional way with surgery( Surgical AVFs) or novel per-cutaneous technique Endo- AVFs.

Investigators will pilot an randomized clinical trial of endo-AVFs and surgical AVFs at University of Alabama at Birmingham to determine the feasibility of patient recruitment, randomization, and retention. This pilot study will set the stage for a full-scale randomized clinical trial in future.

Conditions

  • Dialysis Fistula Creation
  • Endo-vascular AVFs

Interventions

PROCEDURE

Surgical AVF

Surgical fistula creation is standard surgical procedures, where a small cut through the skin is made to create a channel directly between a vein and artery . The study procedures are standard clinical practice, and not considered an experimental procedure.

PROCEDURE

Endo-vascular AVF

Endovascular fistula creation is a minimally invasive procedure used to create a canal between close artery and vein at the forearm. A magnet attached to a catheter is passed over a guidewire into the artery while another magnet passed over the guidewire into the vein. The two magnets are aligned close to each other, then the radiofrequency electrode is released from the venous catheter and energized for 2 seconds, creating a channel between the vein and the artery.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • United States

Study Locations

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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 NCT04404985 on ClinicalTrials.gov