Levant 2 Continued Access Registry

A Prospective, Multicenter, LEVANT 2 Continuation Registry of the Moxy™ Drug Coated Balloon for Treatment of Femoropopliteal Arteries

Levant 2 Continued Access Registry [NCT01628159]

Description:   The purpose of the study is to collect additional safety and efficacy information on the Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the femoral and popliteal arteries.

Device: Lutonix Drug Coated Balloon

Primary Investigator: Hunter

Drug/Device Information
Moxy™ Drug Coated Balloon (Paclitaxel) of Femoropopliteal Arteries
Non randomized, open label
C. R. Bard
Major Inclusion and Exclusion
Length ≤ 15 cm
Diameter between ≥ 4 and ≤ 6 mm
Lesion is at least 3 cm from any stent
Creatinine ≤ 2.5