LDL Apheresis-mediated Endothelial Activation Therapy to Severe-Peripheral Artery Disease (LETS-PAD) Study: Rationale and Study Design.

A novel approach is required for standard therapy-resistant peripheral arterial disease. This is a single-center, single-arm, interventional study (LDL Apheresis-mediated Endothelial Activation Therapy to Severe-Peripheral Artery Disease study), which aims to evaluate the efficacy and safety of lipoprotein apheresis with a dextran sulfate cellulose column in peripheral arterial disease with controlled serum cholesterol levels. The study participants have standard therapy-resistant peripheral arterial disease with controlled serum cholesterol levels. A total of 35 patients undergo 10 sessions of lipoprotein apheresis therapy. The ankle-brachial index and vascular quality of life (VascuQol) questionnaire are assessed before and after the treatment period as primary outcomes. Registration of patients began on November 2015 and is planned to be concluded in October 2020. This article is protected by copyright. All rights reserved.