Celect Vena Cava Filter Clinical Trial

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2009-03-31

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.

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Detailed Description

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Conditions

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Pulmonary Embolism Venous Thromboembolism

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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1

Vena Cava Filter

Group Type EXPERIMENTAL

Celect Vena Cava Filter

Intervention Type DEVICE

Effective filtration of inferior vena cava blood to prevent thromboembolism.

Interventions

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Celect Vena Cava Filter

Effective filtration of inferior vena cava blood to prevent thromboembolism.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No