NCT01412541

Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries

A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 532 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to demonstrate the superior efficacy and non-inferior safety of the Moxy Drug Coated Balloon by direct comparison to standard percutaneous transluminal angioplasty (PTA) catheter for treatment of stenosis of the femoropopliteal arteries.

Detailed description

The Moxy Drug Coated Balloon is indicated for percutaneous transluminal angioplasty of obstructive de novo or non-stented restenotic lesions in native femoropopliteal arteries up to 15 cm in length and ≥4.0 to ≤6.0 mm in diameter. This study will randomize approximately 476 patients who will receive either the Moxy balloon or standard balloon angioplasty at 55 global investigational sites. Subjects will be blinded to treatment until 12 months and will participate in long term follow-up for 5 years.

Conditions

• Femoral Artery Stenosis
• Popliteal Artery Stenosis
• Femoral Artery Occlusion
• Popliteal Artery Occlusion

Interventions

Type	Name	Description
PROCEDURE	Standard Uncoated Angioplasty Balloon	Subjects will be randomized 2:1 to the Moxy Drug Coated Balloon or Standard Angioplasty Balloon
DEVICE	Moxy Drug Coated Balloon	Subjects will be randomized 2:1 to the drug coated or standard angioplasty balloon

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-11-01
• Completion: 2018-12-01
• First posted: 2011-08-09
• Last updated: 2020-05-12
• Results posted: 2016-03-29

Locations

54 sites across 4 countries: United States, Austria, Belgium, Germany