NCT02183194

Paclitaxel Coated PTA Balloons for Treatment of Dysfunctional AV Fistulae and Grafts

A Prospective, MultiCenter, Single-arm, Post-market Study of Paclitaxel Coated PTA Balloons for Treatment of Dysfunctional AV Fistulae and Grafts (ACCESS)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the Lutonix® 035 Drug Coated Balloon PTA Catheter (CE mark) for use as intended in the treatment of subjects with clinically significant hemodialysis vascular access stenosis or occlusion.

Conditions

• Dysfunctional AV Graft
• Dysfunctional AV Fistula

Interventions

Type	Name	Description
DEVICE	Lutonix Paclitaxel Drug Coated Balloon

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-07-08
• Last updated: 2016-02-02

Locations

4 sites across 2 countries: Austria, Germany