Novel Endovascular Access Trial (NEAT)

C. R. Bard

Status: Completed

Conditions: Chronic Kidney Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02036671

VAP-0001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

EndoAVF

Experimental group

Description:

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

Treatment:

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