Celect Vena Cava Filter Clinical Trial

Cook Group

Status

Completed

Conditions

Venous Thromboembolism

Pulmonary Embolism

Treatments

Device: Celect Vena Cava Filter

Study type

Interventional

Funder types

Industry

Identifiers

NCT00470626

05-507

110006, GTMX

Details and patient eligibility

About

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.

Enrollment

129 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.