Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae (SAVE)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01471041 |
Recruitment Status
:
Completed
First Posted
: November 11, 2011
Results First Posted
: June 3, 2016
Last Update Posted
: June 3, 2016
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
End Stage Renal Disease AV Fistula Kidney Failure | Device: Venous Window Needle Guide | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 54 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Vital Access Venous Window Needle Guide for Salvage of AV FistulaE (SAVE) Trial |
Study Start Date : | December 2011 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
---|---|
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
|
- 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.
- 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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01471041
United States, California | |
Ladenheim Dialysis Access Centers | |
Fresno, California, United States, 93710 | |
United States, Oklahoma | |
University of Oklahoma - Tulsa | |
Tulsa, Oklahoma, United States, 74104 |
Study Director: | Mark Crawford, BA | Vital Access |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Vital Access Corp. |
ClinicalTrials.gov Identifier: | NCT01471041 History of Changes |
Other Study ID Numbers: |
VA 024 |
First Posted: | November 11, 2011 Key Record Dates |
Results First Posted: | June 3, 2016 |
Last Update Posted: | June 3, 2016 |
Last Verified: | April 2016 |
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 Fistula Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic Pathological Conditions, Anatomical |
Arteriovenous Malformations Vascular Malformations Cardiovascular Abnormalities Cardiovascular Diseases Vascular Fistula Vascular Diseases Congenital Abnormalities |