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

Phase 2

Completed

• Conditions: Kidney Failure; AV Fistula; End Stage Renal Disease
• Interventions: Device: Venous Window Needle Guide

• Registration Number: NCT01471041
• Lead Sponsor: Vital Access Corp.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-01
• Study First Submitted QC: 2011-11-09
• Study First Posted: 2011-11-11
• Study Start: 2011-12
• Primary Completion: 2013-03
• Study Completion: 2013-06
• Status Verified: 2016-04
• Results First Submitted: 2016-04-26
• Results First Submitted QC: 2016-04-26
• Last Update Submitted: 2016-04-26
• Results First Posted: 2016-06-03
• Last Update Posted: 2016-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Venous Window Needle Guide	Venous Window Needle Guide	Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula

Primary Outcome Measures

Name	Time	Method
Use of Venous Window Needle Guide to Obtain Arteriovenous Access for Hemodialysis	3 months	Successful cannulation of arteriovenous fistula through the VWNG device and successful hemodialysis achieved within 3 months from index procedure.

Secondary Outcome Measures

Name	Time	Method
Arteriovenous Fistula Cannulation Complications While Using the Venous Window Needle Guide	6 months	Frequency of complications occuring when cannulating the arteriovenous fistula through the Venous Window Needle Guide

Trial Locations

Locations (2)

Ladenheim Dialysis Access Centers; 🇺🇸 Fresno, California, United States

University of Oklahoma - Tulsa; 🇺🇸 Tulsa, Oklahoma, United States