Phase 3
N=54
Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae
End Stage Renal Disease · AV Fistula · Kidney Failure
Bottom Line
View on ClinicalTrials.gov: NCT01471041 ↗Enrolled (actual)
54
Serious AEs
14.8%
Results posted
Jun 2016
Primary outcome: Primary: Use of Venous Window Needle Guide to Obtain Arteriovenous Access for Hemodialysis — 49 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Venous Window Needle Guide (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vital Access Corp.
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Use of Venous Window Needle Guide to Obtain Arteriovenous Access for Hemodialysis |
49 | — |
| SECONDARY Arteriovenous Fistula Cannulation Complications While Using the Venous Window Needle Guide |
14 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT01471041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.