NCT00930813

LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis

A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Lutonix Catheter vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries With and Without Stenting.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the safety and efficacy of the Lutonix Catheter for treatment of stenosis of the femoropopliteal arteries by direct comparison to standard balloon angioplasty.

Detailed description

The LEVANT I trial will enroll patients presenting with clinical evidence of claudication or critical limb ischemia and an angiographically significant lesion in the femoropopliteal arteries. Patients will be randomized to treatment with either the Lutonix Catheter or standard balloon angioplasty after predilation.

Conditions

• Atherosclerosis
• Vascular Disease
• Arteriosclerosis

Interventions

Type	Name	Description
DEVICE	Lutonix Catheter	Paclitaxel Coated Balloon Catheter
DEVICE	Standard uncoated Balloon Angioplasty Catheter	plain, uncoated angioplasty balloon catheter

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-06-01
• Completion: 2011-12-01
• First posted: 2009-07-02
• Last updated: 2015-12-21
• Results posted: 2015-12-21

Locations

10 sites across 2 countries: Belgium, Germany