Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae

End Stage Renal Disease Clinical Trial

— SAVE  

Official title:

Vital Access Venous Window Needle Guide for Salvage of AV FistulaE (SAVE) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01471041
• Other study ID #: VA 024
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 1, 2011
• Last updated: August 27, 2013
• Start date: December 2011
• Est. completion date: June 2013

Study information

• Verified date: August 2013
• Source: Vital Access Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriovenous Fistula
• AV Fistula
• End Stage Renal Disease
• Fistula
• Kidney Diseases
• Kidney Failure
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Device:
• Venous Window Needle Guide
Subcutaneous, extravascular needle guide made of medical-grade titanium

Locations

Country	Name	City	State
United States	Ladenheim Dialysis Access Centers	Fresno	California
United States	University of Oklahoma - Tulsa	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Vital Access Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of Venous Window Needle Guide to obtain arteriovenous access for hemodialysis	Successful cannulation of arteriovenous fistula through the VWNG device and successful hemodialysis achieved within 3 months from index procedure.	3 months	No
Secondary	Arteriovenous fistula cannulation complications while using the Venous Window Needle Guide	Frequency of complications occuring when cannulating the arteriovenous fistula through the Venous Window Needle Guide	6 months	Yes