Celect Vena Cava Filter Clinical Trial - Tabular View

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

July 14, 2009

Start Date ^ICMJE

November 2005

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The composite Major Adverse Event (MAE) rate for the Celect Vena Cava Filter will be significantly less than the 50% MAE for vena cava filters found in the literature. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

The composite Major Adverse Event (MAE) rate for the Celect Vena Cava Filter will be significantly less than the 50% MAE for vena cava filters found in the literature.

Change History

Complete list of historical versions of study NCT00470626 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Celect Vena Cava Filter Clinical Trial

Official Title ^ICMJE

Prospective Study of the Cook Celect Filter, Including Permanent and Retrievable Use

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 thromboembolism.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Pulmonary Embolism
Venous Thromboembolism

Intervention ^ICMJE

Device: Celect Vena Cava Filter

Study Arms / Comparison Groups

Experimental: Vena Cava Filter

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

129

Completion Date

March 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria (Implant Group):

The patient is at high risk for pulmonary embolism and is under consideration for placement of a permanent IVC filter.
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.

Inclusion Criteria (Retrieval Group):

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 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 Criteria (Implant Group):

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

Exclusion Criteria (Retrieval Group):

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, Germany, Mexico, Spain, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00470626

Responsible Party

Michael Seest, William Cook Europe

Study ID Numbers ^ICMJE

05-507, 110006, GTMX

Study Sponsor ^ICMJE

Cook

Collaborators ^ICMJE

MED Institute, Incorporated
William Cook
William Cook Europe
Cook Ireland, Ltd.

Investigators ^ICMJE

Principal Investigator:

R.W. Gunther, Prof.

Klinik Fur Radiologische Diagnostik Universitaetklinikum der RWTH Aachen

Information Provided By

Cook

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP