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Status:

COMPLETED

Celect Vena Cava Filter Clinical Trial

Lead Sponsor:

Cook Group Incorporated

Collaborating Sponsors:

MED Institute, Incorporated

William Cook Australia

Conditions:

Pulmonary Embolism

Venous Thromboembolism

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

November 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2009

Estimated Enrollment :

129 Patients enrolled

Trial Details

Trial ID

NCT00470626

Start Date

November 1 2005

End Date

March 1 2009

Last Update

January 25 2016

Active Locations (8)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (8 locations)

1

The Alfred Hospital

Melbourne, Australia, 3181

2

RWTH Aachen University

Aachen, Germany, D-52057

3

Instituto Nacional de Enfermedades Respiratorias

Mexico City, Mexico, 14080

4

Hospital Universitario de Nuevo Leon

Monterrey, Mexico, 64460