NCT03795038

Comparison of the Plasma Lipoprotein Apheresis Systems DIAMED and MONET vs. the Whole Blood Apheresis System DALI

Comparison of the Plasma Lipoprotein Apheresis Systems DIAMED and MONET vs. the Whole Blood Apheresis System DALI: Cross-over Study in Patients With Cardiovascular Disease and Severe Dyslipidemia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Fresenius Medical Care Deutschland GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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 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.

Conditions

• Hypercholesterolemia, Familial
• Dyslipidemias
• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	Lipoprotein Apheresis MONET and DALI	Three apheresis treatments assigned to one type of apheresis system of MONETand DALI
DEVICE	Lipoprotein Apheresis DIAMED and DALI	Three apheresis treatments assigned to one type of apheresis system of DIAMOND and DALI

Timeline

• Start date: 2018-12-28
• Primary completion: 2021-05-25
• Completion: 2021-05-25
• First posted: 2019-01-07
• Last updated: 2022-07-28

Locations

2 sites across 1 country: Germany