Crux Biomedical Vena Cava Filter Study - United States

Study Overview
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Brief Summary
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The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and effective in preventing pulmonary embolism.

Official Title
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Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 2

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Device: Inferior Vena Cava Filter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has a permanent or temporary risk of Pulmonary Embolism Patient or legal guardian must provide written informed consent At least one of the following conditions Proven PE Recurrent PE despite adequate anticoagulation Contraindication to anticoagulation Inability to achieve/maintain therapeutic anticoagulation Iliocaval DVT Large, free-floating proximal DVT Massive PE treated with thrombolysis/thrombectomy Chronic PE treated with thrombectomy Procetion during thrombolysis for iliocaval DVT PE with limited cardiopulmonary reserve Poor compliance with anticoagulation medication High risk of injury worsend by anticoagulation Multi-trauma patient with high risk of PE Surgical patients at high risk of PE Medical condition with high risk of PE Patient has documented vena cava diameter of 17-28mm Patient has IVC anatomy suitable for infra-renal placement Patient willing to be available for the appropriate follow up. Exclusion Criteria: Age <18 years old Patient has any one of the following conditions Renal vein thrombosis IVC thrombosis extending to te renal veins Duplicate IVC Gonadal vein thrombosis Requires supra-renal placement Uncontrolled infectious disease Risk of aseptic PE Uncontrolled coagulopathy Existing inferior vena cava filter implant Life expectancy less than 6 months Pregnant or planning a pregnancy in the next 6 months Condition that inhibits radiographic visualization of the IVC Known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol Known hypersensitivity to contract which cannot be pretreated Access vessels preclude safe insertion of delivery system Participation in another drug or device trial Unable or unwilling to cooperate with study procedures or required follow-up visits

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: Crux Vena Cava Filter System<br>Subjects at risk for Pulmonary Embolism | Device: Inferior Vena Cava Filter<br>* Inplant of filter in inferior vena cava.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success | Clinical Success is a composite endpoint consisting of technical success with freedom from pulmonary embolism, filter migration and device related events requiring intervention. | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrieval Success |  | 6 Months | 
| Filter Migration |  | 6 Months | 
| VCF Thrombus |  | 6 Months | 
| Device Integrity |  | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vena Cava, Vena Cava Filter, Pulmonary Embolism, Venous Thromboembolism, Risk of Pulmonary Embolism