Celect Vena Cava Filter Clinical Trial

Study Overview
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Brief Summary
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The clinical study will collect data to verify the safety and performance of the Cook Celect Filter in the prevention of pulmonary embolism (PE) in patients with a temporary or permanent high risk of thromboembolism.

Official Title
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Prospective Study of the Cook Celect Filter, Including Permanent and Retrievable Use

Conditions
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Pulmonary Embolism, Venous Thromboembolism

Intervention / Treatment
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* Device: Celect Vena Cava Filter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is at high risk for pulmonary embolism and is under consideration for placement of a permanent or short-term IVC filter. The patient must have a patent internal jugular vein. The patient or guardian must have given informed consent. The patient must agree to return for clinical imaging follow-up at 1, 3, 6, and 12 months. The patient must agree to have a clinical and imaging examination performed prior to filter retrieval. The patient must agree to return for clinical and imaging follow-up at 30 days and 3 months after filter retrieval. Exclusion Criteria: The patient is less than 18 years of age. The patient is pregnant. The patient has uncontrollable coagulopathy. The patient has a life expectancy less than 6 months. The patient has a vena cava diameter over 30 mm, measured by vena cava sizing catheters. The patient's vena cava diameter is less than 15 mm, measured by vena cava sizing catheters. The patient has a contrast allergy that can not be adequately pre-medicated. The patient is simultaneously participating in another investigative drug or device study, or has a previous IVC filter.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Vena Cava Filter | Device: Celect Vena Cava Filter<br>* Effective filtration of inferior vena cava blood to prevent thromboembolism.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Event | Composite Major Adverse Event includes hemorrhage, perforation, pulmonary embolism, procedure-related or device-related death, occlusion, significant migration and filter fracture. | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Retrieval | Retrieval attempt describes a procedure in which a physician tried to remove a filter from a patient. A decision to remove a filter was made after determining that the patient no longer required the filter. Retrieval attempts were either successful (i.e., the filter was removed) or unsuccessful (i.e., the filter could not be removed and remained in the patient as a permanent device). | up to 12 months | 
| Mean Time to Retrieval Attempt | Mean time to retrieval describes the average time filters were in place in the study group before a retrieval attempt was made. A retrieval attempt describes a procedure in which a physician tried to remove a filter from a patient. The mean time to retrieval describes the average time filters were in place before a retrieval attempt was made. | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Embolism, Venous Thromboembolism, Inferior Vena Cava Filter, IVC, PE