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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hypercholesterolemia, Familial, Dyslipidemias, Cardiovascular Diseases

Intervention / Treatment
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* Device: Lipoprotein Apheresis MONET and DALI
* Device: Lipoprotein Apheresis DIAMED and DALI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent signed and dated by study patient and investigator/authorised physician Minimum age of 18 years Ability to understand the nature and requirements of the study Study-specific inclusion criteria: Patients with indication for lipoprotein apheresis confirmed by a local apheresis expert commission according to the German guidelines [1] and with routine lipoprotein apheresis treatments for at least 3 months. Patients with weekly treatments have not missed more than 3 treatment sessions within the 3 months prior inclusion to the study. Patients with biweekly treatment sessions have not missed more than 1 treatment session within the 3 months prior inclusion to the study Patients with regular weekly or biweekly lipoprotein apheresis treatments with either MONET or DIAMED lipoprotein apheresis systems for at least 4 weeks (weekly treatments) or 8 weeks (biweekly treatments) with the same system With adequate venous access With systolic blood pressure > 100 mmHg With stable hematocrit >35 % With stable anticoagulation Exclusion Criteria: Any condition which could interfere with the patient's ability to comply with the study Pregnancy or lactation period (pregnancy test will be conducted with female patients aged 55 years) Participation in an interventional clinical study during the preceding 30 days or in the same study Study-specific exclusion criteria: Occurrence or clinical relevant deterioration of acute myocardial infarction, unstable angina pectoris, severe hemo-dynamic relevant arrhythmia within 3 months prior inclusion to the study Bypass surgery, vascular diseases, active infection (this means chronic infectious diseases (e.g. chronic hepatitis) and acute infections with a core body temperature ≥ 38.0 °C) or unstable circulation (see exclusion criteria no. 7) within the last 3 months Uncontrolled high or low blood pressure defined as systolic blood pressure >180 mmHg/<100 mmHg and/or diastolic blood pressure >115 mmHg (after three times measuring) Changes in lipid lowering medication within the last 2 weeks Intake of Angiotensin Converting Enzyme (ACE) inhibitor medication within a time interval of five times the terminal half-life of the ACE inhibitor before study start and during the study History of allergic reactions to anticoagulation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Prospective, multicentric, open, interventional, cross-over with randomization
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lipoprotein Apheresis MONET and DALI<br>Patients routinely treated with MONET: The first subgroup will be treated first with the MONET adsorber system for three consecutive treatments followed by a treatment for three consecutive treatments with the DALI adsorber System. The second subgroup will be treated first with the DALI adsorber system for three consecutive treatments followed by a treatment for three consecutive treatments with the MONET adsorber system | Device: Lipoprotein Apheresis MONET and DALI<br>* Three apheresis treatments assigned to one type of apheresis system of MONETand DALI<br>|
| Other: Lipoprotein Apheresis DIAMED and DALI<br>Patients routinely treated with DIAMED: The first subgroup will be treated first with the DIAMED adsorber system for three consecutive treatments followed by a treatment for three consecutive treatments with the DALI adsorber system. The second subgroup will be treated first with the DALI adsorber system for three consecutive treatments followed by a treatment for three consecutive treatments with the DIAMED adsorber System. | Device: Lipoprotein Apheresis DIAMED and DALI<br>* Three apheresis treatments assigned to one type of apheresis system of DIAMOND and DALI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | every week for 6 weeks or biweekly for 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipoprotein apheresis