Novel Endovascular Access Trial (NEAT)

Novel Endovascular Access Trial (NEAT): A Study of the FLEX System for Percutaneous AV Fistula Creation in Hemodialysis Patients

The objective of this study is to evaluate the safety and efficacy of the FLEX System when used to create an arteriovenous fistula (AVF or AV fistula) percutaneously in patients with Chronic Kidney Disease (CKD) who require hemodialysis vascular access.

This is a 12 month multi-center non-randomized investigational study to evaluate the safety and efficacy of the FLEX system to create an endovascular AVF in patients with CKD who require hemodialysis vascular access.

Inclusion Criteria:

• Eligible for a native surgical arteriovenous fistula, as determined by the treating physician.
• Adult (age >18 years old).
• Established, non-reversible kidney failure requiring hemodialysis.
• Written informed consent obtained.

Exclusion Criteria:

• Functioning surgical access in the planned treatment arm.
• Pregnant women.
• New York Heart Association (NYHA) class III or IV heart failure.
• Allergy to contrast dye.