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Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae — AVPAS  

Arteriovenous Fistula Clinical Trial

Official title:
A Prospective, Global, Multicenter, Single Arm Post-Approval Study Investigating the Clinical Use and Safety of the Lutonix® Drug Coated Balloon PTA Catheter for the Treatment of Dysfunctional AV Fistulae

Clinical Trial Summary

This prospective, global, multicenter, single arm post-approval study is designed to investigate the clinical use and safety of the Lutonix® 035 AV Drug Coated Balloon (DCB) PTA Catheter in subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.

Clinical Trial Description

This post-market approval study (PAS) is required by the FDA as a condition of approval for the Lutonix drug coated balloon catheter. It is intended to demonstrate safety and assess the clinical use and outcomes of the LUTONIX Catheter in dysfunctional arteriovenous fistulae (AVF) in a heterogeneous patient population in real world clinical practice. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03506308
Study type Interventional
Source C. R. Bard
Contact Bradley Forsyth, MBA
Phone 385-583-9259
Email bradley.forsyth@bd.com
Status Recruiting
Phase N/A
Start date August 7, 2018
Completion date September 2029
View Details
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