InnaVasc

Official Title

Clinical Trial Title    A Study to Evaluate the Safety and Effectiveness of the InnaVasc Arteriovenous Graft for Hemodialysis Access in Patients with End-Stage Renal Disease (InnaVasc)

Study Purpose

This clinical trial is a prospective, multi-center, single-arm study designed to assess the safety and effectiveness of the IG device in subjects with ESRD who require hemodialysis.

Diagnosis

Patients with ESRD whose next most appropriate option for AV access is placement of an AV graft to start or maintain hemodialysis therapy.

Eligibility

Exclusion

• Severe cardiac disease
• Uncontrolled diabetes, hypotension, or hypertension
• Severe peripheral artery disease
• Recent stroke
• Recent cancer
• Immunodeficiency
• Scheduled transplant within 6 months

Intervention

Subjects will be implanted with an IG in the forearm or upper arm using standard vascular surgical techniques.