The clinical Investigation will be performed to compare the safety and effectiveness of the CE certified and established lipoprotein apheresis systems MONET vs. DALI and DIAMED vs. DALI for optimizing the individual therapy of patients with severe dyslipidemia using established and novel efficacy parameters.
Comparison of the safety and effectiveness of the CE certified and established lipoprotein apheresis systems MONET vs. DALI and DIAMED vs. DALI for optimizing the individual therapy of patients with severe dyslipidemia using established and novel efficacy parameters. The primary objective is to compare the whole blood lipoprotein apheresis system DALI with the plasma lipoprotein apheresis systems MONET and DIAMED with regard to their efficacies in removing total cholesterol, low density lipoprotein cholesterol (LDL-C), triglycerides and lipoprotein (a) (Lp(a)). The secondary objective is to compare the whole blood lipoprotein apheresis system DALI with the plasma lipoprotein apheresis system MONET and DIAMED with regard to their efficacies in removing other novel efficacy parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Three apheresis treatments assigned to one type of apheresis system of MONETand DALI
Three apheresis treatments assigned to one type of apheresis system of DIAMOND and DALI
Nephrocare Rostock GmbH
Rostock, Mecklenburg-Vorpommern, Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, Saxony, Germany
Removal rate of total cholesterol
Removal rate of total cholesterol as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems
Time frame: every week for 6 weeks or biweekly for 12 weeks
Removal rate of low density lipoprotein cholesterol (LDL-C)
Removal rate of low density lipoprotein cholesterol (LDL-C) as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems
Time frame: every week for 6 weeks or biweekly for 12 weeks
Removal rate of triglycerides
Removal rate of triglycerides as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems
Time frame: every week for 6 weeks or biweekly for 12 weeks
Removal rate of lipoprotein (a) (Lp(a)).
Removal rate of lipoprotein (a) (Lp(a)) as primary endpoint in blood samples to evaluate the clinical performance of the apheresis systems
Time frame: every week for 6 weeks or biweekly for 12 weeks
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