Comparison of the Plasma Lipoprotein Apheresis Systems DIAMED and MONET vs. the Whole Blood Apheresis System DALI
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cardiovascular Diseases
- Dyslipidemias
- Hypercholesterolemia, Familial
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Prospective, multicentric, open, interventional, cross-over with randomizationMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 comp...
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.
Tracking Information
- NCT #
- NCT03795038
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Heinrich Prophet, Dr. med. Nephrocare Rostock GmbH
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