Status:
COMPLETED
Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae
Lead Sponsor:
Vital Access Corp.
Conditions:
End Stage Renal Disease
AV Fistula
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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.
Eligibility Criteria
Inclusion
- Deep, uncannulatable, upper extremity arteriovenous fistula
- Minimum arteriovenous fistula flow 400 ml/min
- One year life expectancy
Exclusion
- Non-transposed basilic or brachial vein arteriovenous fistula
- History of peripheral vascular disease
- History of cardiovascular disease
- History of cerebral vascular disease
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01471041
Start Date
December 1 2011
End Date
June 1 2013
Last Update
June 3 2016
Active Locations (2)
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1
Ladenheim Dialysis Access Centers
Fresno, California, United States, 93710
2
University of Oklahoma - Tulsa
Tulsa, Oklahoma, United States, 74104