Study of IVC Filter Retrieval With the Günther Tulip Vena Cava Filter

Cook Group

Status and phase: Completed; Phase 4

Conditions: Venous Thromboembolism; Pulmonary Embolism

Treatments: Device: Günther Tulip Vena Cava Filter

Study type: Interventional

Funder types: Industry

Identifiers

NCT00196118

04-507-01

Details and patient eligibility

About

The purpose of this study is to test the hypothesis that the Günther Tulip Vena Cava Filter can be removed after a period of implantation, when implanted in patients for the prevention of pulmonary thromboembolism.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient must be considered at high risk for PE, but placement of a permanent IVC filter is not likely to be required.
• Patient must have a patent internal jugular vein.
• Patient has given informed consent.

Exclusion criteria

• Patient is less than 18 years.
• Patient has a pre-existing filter
• Patient had indications for a permanent filter at the time of the initial evaluation.
• Patient has uncontrollable coagulopathy.
• Patient has a short life expectancy < 6 months.
• Patient has metastatic malignancy.
• Patient has a vena cava diameter over 30 mm, measured by vena cava sizing catheters.
• Patient has a contrast allergy that cannot be adequately pre-medicated.
• Patient is at risk of septic embolism.
• Patient has sepsis.
• Patient has a hypersensitivity to any of the components of the GT filter, specifically cobalt, nickel, and chromium.
• Patient has impaired renal function (creatinine > 2.0).
• Patient is pregnant or planning to become pregnant within the next 6 months