Novel Endovascular Access Trial (NEAT)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-10-31

Brief Summary

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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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Detailed Description

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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

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Chronic Kidney Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EndoAVF

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Interventions

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No