Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae
- Conditions
- Kidney FailureAV FistulaEnd Stage Renal Disease
- Registration Number
- NCT01471041
- Lead Sponsor
- Vital Access Corp.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- Deep, uncannulatable, upper extremity arteriovenous fistula
- Minimum arteriovenous fistula flow 400 ml/min
- One year life expectancy
- Non-transposed basilic or brachial vein arteriovenous fistula
- History of peripheral vascular disease
- History of cardiovascular disease
- History of cerebral vascular disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Use of Venous Window Needle Guide to Obtain Arteriovenous Access for Hemodialysis 3 months Successful cannulation of arteriovenous fistula through the VWNG device and successful hemodialysis achieved within 3 months from index procedure.
- Secondary Outcome Measures
Name Time Method Arteriovenous Fistula Cannulation Complications While Using the Venous Window Needle Guide 6 months Frequency of complications occuring when cannulating the arteriovenous fistula through the Venous Window Needle Guide
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (2)
Ladenheim Dialysis Access Centers
🇺🇸Fresno, California, United States
University of Oklahoma - Tulsa
🇺🇸Tulsa, Oklahoma, United States
Ladenheim Dialysis Access Centers🇺🇸Fresno, California, United States