NCT02036671

Novel Endovascular Access Trial (NEAT)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DEVICE	The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-12-01
• Completion: 2016-10-01
• First posted: 2014-01-15
• Last updated: 2025-11-26

Locations

9 sites across 3 countries: Australia, Canada, New Zealand