A Prospective Clinical Evaluation of the TVA FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction

C. R. Bard1 site in 1 country17 target enrollmentApril 1, 2013

ConditionsChronic Kidney Disease (CKD)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Kidney Disease (CKD)
Sponsor: C. R. Bard
Enrollment: 17
Locations: 1
Primary Endpoint: Adverse Events
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 1, 2013

End Date

February 1, 2014

Last Updated

5 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

C. R. Bard

Responsible Party

Sponsor

Eligibility Criteria

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