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Clinical Trial Summary

The purpose of this Registry is to enroll patients presenting with clinical and hemodynamic abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the arm. Subjects will be treated with the Lutonix DCB carrying the CE Mark per current IFU and followed clinically for a minimum of 12 months.


Clinical Trial Description

This post market registry is intended to demonstrate safety and assess the clinical use and outcomes of the Lutonix DCB in a heterogeneous patient population with dysfunctional native or synthetic AV fistulae in real world clinical practice. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02746159
Study type Observational [Patient Registry]
Source C. R. Bard
Contact
Status Completed
Phase
Start date June 7, 2016
Completion date March 9, 2019

See also
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