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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Vital Access Corp.

ClinicalTrials.gov Identifier:

NCT01471041

First received: November 1, 2011

Last updated: April 26, 2016

Last verified: April 2016

History of Changes

Purpose

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.

Condition	Intervention	Phase
End Stage Renal Disease AV Fistula Kidney Failure	Device: Venous Window Needle Guide	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Vital Access Venous Window Needle Guide for Salvage of AV FistulaE (SAVE) Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Parkes Weber syndrome capillary malformation-arteriovenous malformation syndrome

MedlinePlus related topics: Fistulas Kidney Failure

U.S. FDA Resources

Further study details as provided by Vital Access Corp.:

Primary Outcome Measures:

Use of Venous Window Needle Guide to Obtain Arteriovenous Access for Hemodialysis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Successful cannulation of arteriovenous fistula through the VWNG device and successful hemodialysis achieved within 3 months from index procedure.

Secondary Outcome Measures:

Arteriovenous Fistula Cannulation Complications While Using the Venous Window Needle Guide [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Frequency of complications occuring when cannulating the arteriovenous fistula through the Venous Window Needle Guide


Enrollment:	54
Study Start Date:	December 2011
Study Completion Date:	June 2013
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Venous Window Needle Guide Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula	Device: Venous Window Needle Guide Subcutaneous, extravascular needle guide made of medical-grade titanium Other Name: VWNG

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01471041

Locations


United States, California
Ladenheim Dialysis Access Centers
Fresno, California, United States, 93710
United States, Oklahoma
University of Oklahoma - Tulsa
Tulsa, Oklahoma, United States, 74104

Sponsors and Collaborators

Vital Access Corp.

Investigators


Study Director:	Mark Crawford, BA	Vital Access

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Jennings WC, Galt SW, Shenoy S, Wang S, Ladenheim ED, Glickman MH, Kathuria P, Browne BJ. The Venous Window Needle Guide, a hemodialysis cannulation device for salvage of uncannulatable arteriovenous fistulas. J Vasc Surg. 2014 Oct;60(4):1024-32. doi: 10.1016/j.jvs.2014.04.016. Epub 2014 May 13.


Responsible Party:	Vital Access Corp.
ClinicalTrials.gov Identifier:	NCT01471041 History of Changes
Other Study ID Numbers:	VA 024
Study First Received:	November 1, 2011
Results First Received:	April 26, 2016
Last Updated:	April 26, 2016
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vital Access Corp.:


End Stage Renal Disease Hemodialysis AV fistula Kidney failure

Additional relevant MeSH terms:


Arteriovenous Fistula Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic Fistula Renal Insufficiency Urologic Diseases Pathological Conditions, Anatomical	Arteriovenous Malformations Vascular Malformations Cardiovascular Abnormalities Cardiovascular Diseases Vascular Fistula Vascular Diseases Congenital Abnormalities

ClinicalTrials.gov processed this record on September 23, 2016

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