Clinical Study to Evaluate the Efficacy of Blood Purification Therapy on Cholesterol Crystal Embolism

Study Overview
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Brief Summary
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The aim of this study is to evaluate efficacy and safety of blood purification therapy on renal dysfunction by cholesterol crystal embolism.

Official Title
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Clinical Study to Evaluate the Efficacy of Blood Purification Therapy on Cholesterol Crystal Embolism

Conditions
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Cholesterol Embolism

Intervention / Treatment
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* Device: Liposorber LA-15 System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who meet all of the following criteria. Patients who had cardiac catheterization or vascular surgery in the last 24 weeks before the time of obtaining informed consent. Patients who satisfy all of the following criteria or are diagnosed as CCE by skin or renal biopsy. Patients with progressive renal dysfunction in the course of weeks or months. Patients with skin lesions such as livedo reticularis of lower extremities or blue toe syndrome. Eosinophil count is more than 400 per microliter. Patients who or patients whose legal representative understood the requirements of the study and signed the informed consent forms. Exclusion Criteria: Patients who meet any of the following criteria will be excluded. Patients with contraindication to anticoagulant (Nafamostat Mesilate). Blood purification therapy is inapplicable because of severe heart failure, acute myocardial infarction, severe arrhythmia, acute stroke, or severe uncontrollable hypertension or hypotension. Patients with body weight less than 40kg. Patients with a history of allergic reaction or hypersensitivity to blood purification. Patients who cannot stop taking ACE inhibitors. Patients with any disease in which corticosteroid, statin are contraindicated. Patients participated in another clinical trial or study at the time of obtaining informed consent. Patients receiving chronic hemodialysis. Otherwise, patients who are judged by the investigator as being unsuitable for inclusion in the study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposorber LA-15 System<br> | Device: Liposorber LA-15 System<br>* Six sessions of blood purification treatment with Liposorber LA-15 System.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of chronic hemodialysis |  | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose of drugs |  | Six months | 
| Incidence of lower limb amputation |  | Six months | 
| Incidence of gangrene |  | Six months | 
| Incidence of multi organ failure |  | Six months | 
| Survival rate |  | Six months | 
| Incidence of adverse events |  | Six months |