Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Hospital |
| Therapuetic Areas: | Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/30/-0001 |
| Start Date: | December 2011 |
| End Date: | October 2012 |
| Contact: | Mark Crawford |
| Email: | mcrawford@vital-access.com |
| Phone: | 801-433-9390 |
Vital Access Venous Window Needle Guide for Salvage of AV FistulaE (SAVE) Trial
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.
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
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