CompletedNot Applicable

Novel Endovascular Access Trial (NEAT)

Australia, Canada80 participantsStarted 2014-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Primary Efficacy Endpoint:

Timeframe: within 3 months

Trial details

NCT IDNCT02036671

SponsorC. R. Bard

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-12

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