Phase 3
Completed N=54
Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae
End Stage Renal Disease · AV Fistula · Chronic Kidney Disease
Source: ClinicalTrials.gov NCT01471041 ↗
Enrolled (actual)
54
Serious AEs
14.8%
Results posted
Jun 2016
Primary outcomePrimary: Use of Venous Window Needle Guide to Obtain Arteriovenous Access for Hemodialysis — 49 participants
◆ Published Evidence
Established
29citations · ~2 / year
The Venous Window Needle Guide, a hemodialysis cannulation device for salvage of uncannulatable arteriovenous fistulas.
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.
Linked Publications
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The Venous Window Needle Guide, a hemodialysis cannulation device for salvage of uncannulatable arteriovenous fistulas.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.