Skip to main content
OpenTrials
Completed

NCT Number: NCT00196118

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Christiana Hospital, Newark, Delaware, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Günther Tulip Vena Cava Filter

Device

Primary outcomes

  1. The rate of successful filter retrieval following implant.

Secondary outcomes

  1. The rate of complications related to Inferior Vena Cava Filter use.

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

A Non-Randomized Prospective Study of IVC Filter Retrieval

Important dates

Study start
2005
Study completion
2007
First posted
Sep 20, 2005
Registry last updated
Dec 11, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.