RexMedical- Option* Vena Cava Filter IDE Study

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

2006-10-31

Study Completion Date

2009-06-30

Brief Summary

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This study is designed to evaluate the safety and efficacy of the RexMedical Option\* Vena Cava Filter in the treatment of patients who are at increased risk for Pulmonary Embolism and require caval interruption.

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Detailed Description

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Conditions

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Pulmonary Embolism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intravascular Filter Device

Group Type OTHER

Intravascular Filter Device

Intervention Type DEVICE

Vena cava filter which is implanted into the inferior vena cava of patients to prevent recurrent pulmonary embolism. The filter can be utilized as a permanent or retrievable device.

Interventions

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Intravascular Filter Device

Vena cava filter which is implanted into the inferior vena cava of patients to prevent recurrent pulmonary embolism. The filter can be utilized as a permanent or retrievable device.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient is at least 18 years of age
* Patient requires temporary or permanent caval interruption

Exclusion Criteria

* Patient has pre-existing filter implanted in her/her vasculature or has undergone filter retrieval within 60 days prior to study device implant
* Patient is currently enrolled in another investigational device or drug trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No