NCT00196118

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2005

Typical duration for phase_4

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

December 11, 2007

Status Verified

December 1, 2007

First QC Date

September 12, 2005

Last Update Submit

December 7, 2007

Conditions

Pulmonary EmbolismVenous Thromboembolism

Keywords

Pulmonary EmbolismVenous ThromboembolismInferior Vena Cava FilterIVCPE

Outcome Measures

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.

Interventions

Günther Tulip Vena Cava FilterDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Christiana Hospital

Newark, Delaware, 19718, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Baptist Hospital of Miami, Inc.: Baptist Cardiac & Vascular Institute

Miami, Florida, 33176, United States

Location

Atlanta Medical Center

Atlanta, Georgia, 30312, United States

Location

University of Chicago Hospital

Chicago, Illinois, 60637, United States

Location

OSF St. Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Spectrum Health Butterworth & Blodgett Campuses

Grand Rapids, Michigan, 49503, United States

Location

Oregon Health & Sciences University

Portland, Oregon, 97201, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Utah Valley Regional Medical Center Department of Radiology

Provo, Utah, 84605, United States

Location

LDS Hospital: Department of Radiology

Salt Lake City, Utah, 84103, United States

Location

INOVA Alexandria

Alexandria, Virginia, 22304, United States

Location

MeSH Terms

Conditions

Pulmonary EmbolismVenous Thromboembolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesThromboembolism

Study Officials

  • Bob Smouse, MD

    Peoria Radiology Research & Education Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

April 1, 2005

Study Completion

July 1, 2007

Last Updated

December 11, 2007

Record last verified: 2007-12

Locations

US(17)