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Completed

NCT Number: NCT01471041

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

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.

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Key information

Conditions

End Stage Renal Disease AV Fistula Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Kidney Diseases Kidney Failure Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ladenheim Dialysis Access Centers, Fresno, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Venous Window Needle Guide

Device

Subcutaneous, extravascular needle guide made of medical-grade titanium

Other names: VWNG

Primary outcomes

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

    Time frame: 3 months

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

Secondary outcomes

  1. Arteriovenous Fistula Cannulation Complications While Using the Venous Window Needle Guide

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Vital Access Corp.

Industry

Registry information

Official study title

Vital Access Venous Window Needle Guide for Salvage of AV FistulaE (SAVE) Trial

Acronym: SAVE

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 11, 2011
Registry last updated
Jun 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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