Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae
SAVE
Vital Access Venous Window Needle Guide for Salvage of AV FistulaE (SAVE) Trial
1 other identifier
interventional
54
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2011
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2011
CompletedFirst Posted
Study publicly available on registry
November 11, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
June 3, 2016
CompletedJune 3, 2016
April 1, 2016
1.2 years
November 1, 2011
April 26, 2016
April 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 months
Secondary Outcomes (1)
Arteriovenous Fistula Cannulation Complications While Using the Venous Window Needle Guide
6 months
Study Arms (1)
Venous Window Needle Guide
EXPERIMENTALVenous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula
Interventions
Subcutaneous, extravascular needle guide made of medical-grade titanium
Eligibility Criteria
You may qualify if:
- Deep, uncannulatable, upper extremity arteriovenous fistula
- Minimum arteriovenous fistula flow 400 ml/min
- One year life expectancy
You may not qualify if:
- Non-transposed basilic or brachial vein arteriovenous fistula
- History of peripheral vascular disease
- History of cardiovascular disease
- History of cerebral vascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Ladenheim Dialysis Access Centers
Fresno, California, 93710, United States
University of Oklahoma - Tulsa
Tulsa, Oklahoma, 74104, United States
Related Publications (1)
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.
PMID: 24833247DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mark Crawford
- Organization
- Vital Access
Study Officials
- STUDY DIRECTOR
Mark Crawford, BA
Vital Access
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2011
First Posted
November 11, 2011
Study Start
December 1, 2011
Primary Completion
March 1, 2013
Study Completion
June 1, 2013
Last Updated
June 3, 2016
Results First Posted
June 3, 2016
Record last verified: 2016-04