Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae

Vital Access Corp.54 enrolled

Overview

The SAVE Study will evaluate the safety and efficacy of the Venous Window Needle Guide in achieving access of a deep, un-cannulatable arteriovenous fistula to complete hemodialysis as prescribed.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

End Stage Renal Disease AV Fistula Kidney Failure

Interventions

Venous Window Needle GuideDEVICE

Subcutaneous, extravascular needle guide made of medical-grade titanium

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Deep, uncannulatable, upper extremity arteriovenous fistula * Minimum arteriovenous fistula flow 400 ml/min * One year life expectancy Exclusion Criteria: * Non-transposed basilic or brachial vein arteriovenous fistula * History of peripheral vascular disease * History of cardiovascular disease * History of cerebral vascular disease

Locations (2)

Ladenheim Dialysis Access Centers

Fresno, California, United States

University of Oklahoma - Tulsa

Tulsa, Oklahoma, United States

Outcomes

Primary Outcomes

Use of Venous Window Needle Guide to Obtain Arteriovenous Access for Hemodialysis

Successful cannulation of arteriovenous fistula through the VWNG device and successful hemodialysis achieved within 3 months from index procedure.

Time frame: 3 months

Secondary Outcomes

Arteriovenous Fistula Cannulation Complications While Using the Venous Window Needle Guide

Frequency of complications occuring when cannulating the arteriovenous fistula through the Venous Window Needle Guide

Time frame: 6 months

Data from ClinicalTrials.gov

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