Clinical trial program
Lutonix is committed to the development, execution and reporting of quality clinical trials that add to scientific knowledge and help advance patient care. Here you can learn more about our clinical trial programs, as well as find helpful links to other websites that contain additional research related information.
After extensive pre-clinical development of the Lutonix DCB drug-coated balloon catheter, Lutonix launched an aggressive and FDA compliant First-In-Man clinical trial program in early 2009. These trials, conducted in both the coronary and peripheral settings, were designed as a comprehensive program to establish three key attributes of the Lutonix DCB balloon:
- Biologically effective for inhibiting neointimal hyperplasia (restenosis)
- Feasibility and safety
- Safety when used in conjunction with bare metal stents
Initial results from the First-In-Man Trials will be released at the 2010 Transcatheter Therapeutics Conference in September in Washington D.C. Learn more about our First-In-Man Program.
Future Clinical Trials
Lutonix is planning expanded studies for the treatment of coronary in-stent restenosis and superficial femoral artery disease. Additionally, the company is investigating new areas of potential treatment such as disease in the tibial-peroneal arteries and restenotic AV dialysis grafts. Please continue to visit this page for updates on new clinical trials we are sponsoring.
Enrolling in Future Clinical Trials
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.
As a continuation of the LEVANT I study, the LEVANT II clinical study aims to demonstrate improved results over current standard of care in a larger patient population at expanded clinical sites. Similar to LEVANT I, this study will randomize treatment of patients with a symptomatic lesion in the SFA or popliteal artery to either the Lutonix DCB balloon or standard balloon angioplasty. This study is currently under review with the FDA and approval is pending.
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