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The Lutonix BTK trial is a prospective, multicenter, randomized, controlled trial intended to demonstrate superior efficacy and non-inferior safety of the Lutonix 014 Drug Coated Balloon (DCB) as compared to standard angioplasty balloon catheters for treatment of severe claudication and critical limb ischemia patients with stenotic or occlusive lesions in the below-the-knee arteries. The Lutonix BTK trial is the only on-going DCB trial for BTK arteries in the U.S. and has enrolled more than 450 patients over the past four years.
The Lutonix 014 DCB product for BTK has been commercially available in Europe, Canada and Australia for treatment of the arteries associated with CLI since 2013.
Critical limb ischemia is a severe obstruction of the arteries that seriously decreases blood flow to the lower leg arteries. An estimated 2 million people in the U.S. have CLI today, and the number is estimated to grow to nearly 2.8 million by 2020i. CLI is associated with major amputation rate of 10 percent to 40 percent and with mortality rates as high as 50 percentii.
i Basser O, et al. Prevalence, Incidence, and Outcomes of Critical Limb Ischemia in the US Medicare Population. Vascular Disease Management 2013:10(2):E26-E36.
ii Teraa M, et al. Critical Limb Ischemia: Current Trends and Future Directions. J Am Heart Assoc. 2016;5:e002938