Novel Endovascular Access Trial (NEAT) (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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Device: The FLEX System will be used to percutaneously create a fistula in CKD patients 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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3181
      • Alfred Hospital
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • QE II Health Sciences Center
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre
    • Oshawa, Ontario, Canada, L1G 2B9
      • Lakeridge Health Oshawa
    • Toronto, Ontario, Canada, M5G 2C4
      • The Toronto General Hospital
  • Quebec
    • Montreal, Quebec, Canada, H2L 4M1
      • CHUM, Notre-Dame Hospital
• New Zealand
  • Grafton, New Zealand, 1142
    • Auckland City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EndoAVF; The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access	Device: The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Efficacy Endpoint:	The percentage of patients with fistula maturation/usability defined as endoAVF that is free of stenosis or thrombosis, with brachial artery flow of at least 500 ml/min and at least 4 mm vein diameter (as measured by duplex ultrasound) OR patient was dialyzed using 2 needles.	within 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint	The percentage of patients who experience one or more serious study device related adverse events during the first 3 months following AVF creation	within 3 months
EndoAVF-related Re-intervention Rate	The re-intervention rate for endoAVF (defined as any intervention required to maintain or re-establish patency) will be calculated at 3, 6 and 12 months post index procedure.	3, 6 and 12 months
Primary Patency	Time from successful endoAVF creation to the first intervention designed to address thrombosis or stenosis, assist in maturation or cannulation of endoAVF, or endoAVF abandonment.	3, 6 and 12 months
Cumulative Patency	Time from creation to the abandonment of endoAVF (censor patients with renal transplant)	3, 6 and 12 months
Functional Usability	2-needle cannulation of the endoAVF for prescribed dialysis in ≥ 2/3 of dialysis sessions over a 4 consecutive week period within 12 months of endoAVF creation.	4 weeks post procedure, up to 12 months

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Charmaine Lok, MD, MSC, FRCPC, The Toronto General Hospital; Principal Investigator: Dheeraj Rajan, MD, BSc, FRCPC, FSIR, The Toronto General Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: January 10, 2014
• First Submitted That Met QC Criteria: January 13, 2014
• First Posted (Estimated): January 15, 2014

Study Record Updates

• Last Update Posted (Estimated): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: CKD; Chronic kidney disease; Arteriovenous fistula; Fistula; Percutaneous; Kidney Disease; Kidney Failure, Chronic; Urologic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; hemodialysis
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Renal Insufficiency; Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: VAP-0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No