CompletedNot Applicable

A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction (IR)

Paraguay17 participantsStarted 2013-04

Plain-language summary

The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) including coiling of the brachial vein during the index procedure in patients requiring chronic hemodialysis.

Who can participate

Age range18 Years – 80 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). * Advanced chronic kidney disease (CKD), stage 4 or 5 electing for hemodialysis. * Written informed consent obtained

What they're measuring

Adverse Events

Timeframe: 6 months

Trial details

NCT IDNCT02119832

SponsorC. R. Bard

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-02

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