A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Lutonix DCB Drug-Coated PTA Catheter vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries with and without Stenting.
This ongoing two-year study enrolled 101 subjects between July and November of 2009 at clinical sites in Belgium and Germany. The target population for this study was patients who presented with a symptomatic lesion in either the superficial femoral artery (SFA) or popliteal artery. This study was a randomized trial design to establish safety and efficacy of the Lutonix DCB balloon over standard balloon angioplasty There are currently several options for treating lesions in the leg, however, all have been found to have significant restensosis risks, which lead to further interventions or surgery. The Lutonix DCB balloon is being tested in this population as an alternative treatment for this condition. Six month results for this clinical trial are being released during the Late Breaking Clinical Trial Session at the 2010 Transcatheter Therapeutics Conference in September in Washington D.C.
Click here to review the LEVANT I study presentation from the 2010 TCT.