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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00196118
Other study ID # 04-507-01
Secondary ID
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated December 7, 2007
Start date April 2005
Est. completion date July 2007

Study information

Verified date December 2007
Source Cook
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 800
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Intervention

Device:
Günther Tulip Vena Cava Filter


Locations

Country Name City State
United States INOVA Alexandria Alexandria Virginia
United States Atlanta Medical Center Atlanta Georgia
United States Brigham and Women's Hospital Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States University of Chicago Hospital Chicago Illinois
United States Spectrum Health Butterworth & Blodgett Campuses Grand Rapids Michigan
United States Indiana University Medical Center Indianapolis Indiana
United States Baptist Hospital of Miami, Inc.: Baptist Cardiac & Vascular Institute Miami Florida
United States Christiana Hospital Newark Delaware
United States OSF St. Francis Medical Center Peoria Illinois
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Oregon Health & Sciences University Portland Oregon
United States Rhode Island Hospital Providence Rhode Island
United States Utah Valley Regional Medical Center Department of Radiology Provo Utah
United States LDS Hospital: Department of Radiology Salt Lake City Utah
United States Washington Hospital Center Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Cook

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The rate of successful filter retrieval following implant.
Secondary The rate of complications related to Inferior Vena Cava Filter use.
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