HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia

Study Overview
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Brief Summary
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Assess the effect on coronary atheroma of serial infusions of autologous selectively delipidated HDL/preβ enriched plasma following use of HDL Therapeutics PDS-2™ System

Detailed Description
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The PDS-2™ System is intended to reduce coronary atheroma in patients with Homozygous Familial Hypercholesterolemia (HoFH). Subjects will receive serial infusions of autologous selectively delipidated HDL/preβ enriched plasma following use of HDL Therapeutics' PDS-2 System.

Official Title
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HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia

Conditions
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Homozygous Familial Hypercholesterolemia, HoFH

Intervention / Treatment
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* Device: HDL Therapeutics PDS-2 System


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Clinical diagnosis of Homozygous Familial Hypercholesterolemia (HoFH) due to a defect in the LDL receptor, or the identification of a defect in apoB-100, or a gain of function of PCSK9, or a genetic defect resulting in the HoFH clinical phenotype No other condition that would preclude the subject from successfully completing the series of plasmapheresis visits in the investigator's opinion At least one (1) coronary artery study segment will be identified for each subject and all will remain constant throughout the study. The qualifying study segment(s) will have 20% to 40% stenosis. Key Exclusion Criteria: Planned change in current lipid lowering therapy Use of oral anticoagulants, unless the dose has been stable for 4 weeks LDL or plasma apheresis within 1 week prior to enrollment and through 8-week primary endpoint New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction < 30% Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months of enrollment

Ages Eligible for Study
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Minimum Age: 12 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
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, unblinded, interventional study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HDL Therapeutics PDS-2™ System<br>Serial infusions of autologous selectively delipidated HDL/preβ enriched plasma following use of HDL Therapeutics PDS-2™ System | Device: HDL Therapeutics PDS-2 System<br>* Delipidation of plasma HDL to reduce coronary atheroma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in coronary atheroma | Assessed by coronary imaging in study coronary artery segments following serial infusions of autologous selectively delipidated HDL/preβ enriched plasma following use of HDL Therapeutics PDS-2™ System as compared to baseline | 2 months |