NCT03506308

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 213 (estimated)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Arteriovenous Fistula

Interventions

Type	Name	Description
DEVICE	LUTONIX 035 Drug Coated Balloon PTA Catheter	All subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.

Timeline

• Start date: 2018-08-07
• Primary completion: 2027-04-01
• Completion: 2030-04-01
• First posted: 2018-04-24
• Last updated: 2026-03-18

Locations

26 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study