Back to resultsSafety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae (SAVE)
Primary Purpose
End Stage Renal Disease, AV Fistula, Kidney Failure
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Venous Window Needle Guide
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring End Stage Renal Disease, Hemodialysis, AV fistula, Kidney failure
Eligibility 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
Sites / Locations
- Ladenheim Dialysis Access Centers
- University of Oklahoma - Tulsa
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Venous Window Needle Guide
Arm Description
Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Arteriovenous Fistula Cannulation Complications While Using the Venous Window Needle Guide
Frequency of complications occuring when cannulating the arteriovenous fistula through the Venous Window Needle Guide
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01471041
Brief Title
Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae
Acronym
SAVE
Official Title
Vital Access Venous Window Needle Guide for Salvage of AV FistulaE (SAVE) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vital Access Corp.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, AV Fistula, Kidney Failure
Keywords
End Stage Renal Disease, Hemodialysis, AV fistula, Kidney failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Venous Window Needle Guide
Arm Type
Experimental
Arm Description
Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula
Intervention Type
Device
Intervention Name(s)
Venous Window Needle Guide
Other Intervention Name(s)
VWNG
Intervention Description
Subcutaneous, extravascular needle guide made of medical-grade titanium
Primary Outcome Measure Information:
Title
Use of Venous Window Needle Guide to Obtain Arteriovenous Access for Hemodialysis
Description
Successful cannulation of arteriovenous fistula through the VWNG device and successful hemodialysis achieved within 3 months from index procedure.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Arteriovenous Fistula Cannulation Complications While Using the Venous Window Needle Guide
Description
Frequency of complications occuring when cannulating the arteriovenous fistula through the Venous Window Needle Guide
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Crawford, BA
Organizational Affiliation
Vital Access
Official's Role
Study Director
Facility Information:
Facility Name
Ladenheim Dialysis Access Centers
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
University of Oklahoma - Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24833247
Citation
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.
Results Reference
derived
Learn more about this trial
Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae
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