atherosclerosis
Conditions
Interventions
Subjects will receive serial infusions of autologous selectively delipidated
HDL/pre&beta
-HDL enriched plasma following use of HDL Therapeutics PDS-2 system.
All enrolled subjects will be scheduled for 7 serial infusion visits, 1
infusion per week, within an approximately 7 week infusio
Sponsors
HDL Therapeutics, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Screening stage 1: Presentation with ACS 1. Individual is >= 18 years of age and 20 minutes); - New onset angina (within the past 2 months, of at least Canadian Cardiovascular Society Class III severity); - Increasing angina (previously diagnosed angina that has become distinctly more frequent, longer in duration, or increased by 1 or more Canadian Cardiovascular Society class to at least CCS III severity). b. Cardiac biomarkers (Total CK, CK-MB or Troponin) over the upper limit of normal c. Ischemic ECG changes ;3. Meet the criteria for serial plasmapheresis: • Weight of >= 50 kg (110 lbs.) • Hemoglobin >= 12.5 g/dL • No other condition that would preclude the subject from successfully completing the series of plasmapheresis visits in the investigator*s opinion ;4. Provide written informed consent before any study-specific procedures are performed. The subject must give consent by signing and dating an EC approved consent form. A subject may be excluded for any reason that, in the Investigator*s judgment, interferes with the ability to provide informed consent. ;5. Subjects must be willing to commit to completing all clinic visits and all associated procedures ;Screening stage 2: Angiographic and Central Laboratory Criteria At least one (1) study segment will be identified for each subject and all will remain constant throughout the study. The qualifying study lipid core containing plaque segment(s) will meet all of the following criteria: • 30-80 mm in length • >= 20% and =250 accessible by and as assessed by the TVC Imaging System • Has not undergone previous Coronary Artery Bypass Grafting (CABG) • Has not had a prior percutaneous coronary intervention (PCI) ;6. HDL >=32 mg/dL as assessed by the central laboratory ;7. ApoA-I level of >= 95 mg/dL as assessed by the central laboratory ;8. Fasting triglycerides = 50 kg (110 lbs.) • Hemoglobin >= 12.5 g/dL • Collection of at least 800 ml ( >= 800 ml) of plasma • No other condition that would preclude the subject from successfully completing the series of plasmapheresis visits in the investigator*s opinion - Subject must be willing to commit to completing all clinic visits and the procedures associated with them
Exclusion criteria
Exclusion criteria: Subjects must meet none of the following exclusion criteria prior to enrollment into the trial: ;Screening stage 1: Presentation with ACS 1. ST elevation myocardial infarction (MI) 2mm in at least 2 contiguous precordial leads OR • ST elevation of >1mm in at least 2 limb leads OR • >2mm ST segment depression in precordial leads V1-V2, V2-V3, or V1-V3 OR • Left bundle branch block not previously known to be present ;2. Diabetes mellitus type 1 ;3. Pregnant or lactating women, women who had a pregnancy, regardless of outcome, 3 times upper limit of normal of the reference range during Screening Visits 1 and 2 ;5. Active cholesystitis, gall bladder symptoms, or potential hepato-biliary abnormalities defined as alkaline phosophatase >3 times above the upper limit of the normal reference range. Note: subjects who have had a cholecystectomy are not excluded for this study. ;6. Currently undergoing renal dialysis or presence of renal dysfunction defined as GFR 180 mm Hg and/or diastolic >110 mmHg whether taking or not taking an acceptable concurrent antihypertensive medication ;12. Severe valvular stenosis or regurgitation as defined by ACC/AHA criteria ;13. History of major surgery 50% by visual angiographic estimation ;22. Decreased left ventricular function as evidenced by a left ventricular ejection fraction (LVEF) <40% (within the previous 180 days prior to ACS episode or during ACS hospitalization, evaluation by either echocardiogram or ventriculography) ;Screening stage 3: First infusion visit Subject is considered by his/her attending physician or the investigator to have continued or new hemodynamic i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Lipid core burden in the study lipid core containing plaque segment(s) as assessed by the InfraReDx TVC Imaging System at 2 weeks (± 1 week) following the final (7th) infusion visit paired with the baseline value. 2. Cumulative adverse events, serious adverse events, and unanticipated adverse device events from the start of infusion visit 1 to 8 weeks post-infusion visit 1, with the evaluated adverse events to include but not be limited to, hypotension, n-Butanol solvent toxicity, hypoglycemia, hypocalcemia, and the major adverse cardiac events (MACE) of cardiac death, recurrent ACS (including nonfatal myocardial infarction), ischemic stroke and revascularization of the PCI vessel or the vessel containing the study segment(s). | — |
Countries
Netherlands
Outcome results
None listed