Low‐density‐lipoprotein apheresis‐mediated endothelial activation therapy to severe‐peripheral artery disease study: Rationale and study design

A novel approach is required for standard therapy‐resistant peripheral arterial disease (PAD). 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 o...

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Published in:Therapeutic apheresis and dialysis 2020-10, Vol.24 (5), p.524-529
Main Authors: Ueda, Eiko, Toya, Yoshiyuki, Wakui, Hiromichi, Kawai, Yuki, Azushima, Kengo, Fujita, Takayuki, Saigusa, Yusuke, Yamanaka, Takeharu, Yabuki, Yuichiro, Mikami, Taro, Goda, Motohiko, Sugano, Teruyasu, Tamura, Kouichi
Format: Article
Language:English
Subjects:
dextran sulfate cellulose column
endothelial function
lipoprotein apheresis
normal cholesterol
peripheral arterial disease
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Summary:A novel approach is required for standard therapy‐resistant peripheral arterial disease (PAD). 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 (LA) with a dextran sulfate cellulose column in PAD with controlled serum cholesterol levels. The study participants have standard therapy‐resistant PAD with controlled serum cholesterol levels. A total of 35 patients undergo 10 sessions of LA therapy. The ankle‐brachial index and vascular quality of life questionnaire are assessed before and after the treatment period as primary outcomes. Registration of patients began in November 2015 and is planned to be concluded in October 2020.
ISSN:1744-9979
1744-9987
DOI:10.1111/1744-9987.13546