NCT02440022

Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae

A Prospective, Global, Multicenter, Randomized, Controlled Study Comparing Lutonix® 035 AV Drug Coated Balloon PTA Catheter vs. Standard Balloon PTA Catheter for the Treatment of Dysfunctional AV Fistulae

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 285 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This prospective, global, multicenter, randomized, controlled study is designed to evaluate the safety and effectiveness of the Lutonix 035 AV Drug Coated Balloon PTA Catheter compared to a standard PTA Catheter in treating subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.

Conditions

• Arteriovenous Fistula

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Lutonix DCB
DEVICE	Standard Balloon Angioplasty Catheter
PROCEDURE	Percutaneous Transluminal Angiography	Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-09-01
• Completion: 2018-06-01
• First posted: 2015-05-12
• Last updated: 2020-05-06
• Results posted: 2020-05-06

Locations

23 sites across 1 country: United States