Prospective, Multi-center, Single-arm Study to Assess the Safety of Retrieval of the Recovery G2 Filter.

Study Overview
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Brief Summary
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This study was designed to assess the safety of retrieval of the Bard Recovery® G2® Filter System. The G2 filter is an FDA-cleared device for inferior vena caval interruption in patients with pulmonary thromboembolism.

Official Title
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The Bard® Recovery® Filter Registry (EVEREST) for Patients Who Are Candidates for an Optional (Retrievable) Inferior Vena Cava Filter That Undergo Placement of the Bard® Recovery® Filter.

Conditions
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Pulmonary Embolism, Venous Thromboembolic Disease

Intervention / Treatment
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* Device: Bard Recovery G2 Filter System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is at temporary , increased risk of pulmonary embolism requiring caval interruption Exclusion Criteria: The patient has implanted filter in the IVC or superior vena cava (SVC) The patient has a duplicated or left-sided IVC The patient has a known untreatable or uncontrollable malignancy The patient has severe spinal deformity The patient has a creatinine > 2.0 mg/dl The patient has a life expectancy of < 6 months

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: Filter<br>All subjects enrolled to the study are in this arm. All subjects receive a filter. | Device: Bard Recovery G2 Filter System<br>* Retrieval of previously placed RECOVERY G2 IVC filter<br>* Other names: Bard Recovery G2 Filter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success (Retrieval) | Technical success for retrieval of the filter such that the entire filter is removed. | 1 month post filter retrieval or through 6 months following implantation | 
| Clinical Success (Retrieval) | technical success without subsequent damage to the cava wall or other retrieval-related complications requiring intervention. | Time of Retrieval or through 6 months of implantation | 
| Percentage of Participants With Adverse Events Through 30 Days Post Retrieval | Adverse events occurring at the time of retrieval through 30 days post filter retrieval procedure | 30 days post retrieval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Filter Migration > 2cm | Percentage of subjects experiencing filter migrations from the initial placement position of 2cm or more. | 30 days post retrieval or 6 months following filter placement | 
| Incidence of Filter Fracture | occurrence of fracture assessed at retrieval by the Investigator (broken filter arms, legs, or other components) | at 6 months or at retrieval of the filter | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous Thromboembolic Disease, IVC Filter, Pulmonary Embolism