HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia

HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia

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

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.

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