Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae (AV PAS)
Diseases of the Cardiovascular System
What is the purpose of this trial?
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 PTA Catheter in subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.
- Ages18 years and older
- Trial withLutonix
- Start Date02/26/2019
- End Date03/30/2020
- Last Updated07/24/2019
- Study HIC#2000023345