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Completed

NCT Number: NCT02036671

Novel Endovascular Access Trial (NEAT)

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.

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Key information

Conditions

Chronic Kidney Disease Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Alexandra Hospital, Woolloongabba, Queensland, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

Primary outcomes

  1. Primary Efficacy Endpoint:

    Time frame: within 3 months

    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.

Secondary outcomes

  1. Safety Endpoint

    Time frame: within 3 months

    The percentage of patients who experience one or more serious study device related adverse events during the first 3 months following AVF creation

  2. EndoAVF-related Re-intervention Rate

    Time frame: 3, 6 and 12 months

    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. Primary Patency

    Time frame: 3, 6 and 12 months

    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.

  4. Cumulative Patency

    Time frame: 3, 6 and 12 months

    Time from creation to the abandonment of endoAVF (censor patients with renal transplant)

  5. Functional Usability

    Time frame: 4 weeks post procedure, up to 12 months

    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.

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Registry information

Official study title

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

Acronym: NEAT

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jan 15, 2014
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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