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

Vital Access Corp.

Status and phase: Completed; Phase 3; Phase 2

Conditions: Kidney Failure; AV Fistula; End Stage Renal Disease

Treatments: Device: Venous Window Needle Guide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01471041

VA 024

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Venous Window Needle Guide

Experimental group

Description:

Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula

Treatment:

Device: Venous Window Needle Guide