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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-04-30

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.

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Detailed Description

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Conditions

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Pulmonary Embolism Venous Thromboembolic Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Filter

All subjects enrolled to the study are in this arm. All subjects receive a filter.

Group Type EXPERIMENTAL

Bard Recovery G2 Filter System

Intervention Type DEVICE

Retrieval of previously placed RECOVERY G2 IVC filter

Interventions

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Bard Recovery G2 Filter System

Retrieval of previously placed RECOVERY G2 IVC filter

Intervention Type DEVICE

Other Intervention Names

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Bard Recovery G2 Filter

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No