Celect Vena Cava Filter Clinical Trial - Full Text View

Sponsors and Collaborators:	Cook MED Institute, Incorporated William Cook William Cook Europe Cook Ireland, Ltd.
Information provided by:	Cook
ClinicalTrials.gov Identifier:	NCT00470626

Purpose

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.

Condition	Intervention
Pulmonary Embolism Venous Thromboembolism	Device: Celect Vena Cava Filter

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prospective Study of the Cook Celect Filter, Including Permanent and Retrievable Use

Resource links provided by NLM:

MedlinePlus related topics: Pulmonary Embolism

U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:

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 ]

Enrollment:	129
Study Start Date:	November 2005
Estimated Study Completion Date:	May 2009
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Vena Cava Filter	Device: Celect Vena Cava Filter Effective filtration of inferior vena cava blood to prevent thromboembolism.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470626

Locations

Australia
The Alfred Hospital
Melbourne, Australia, 3181
Germany
RWTH Aachen University
Aachen, Germany, D-52057
Mexico
Hospital Universitario de Nuevo Leon
Monterrey, Mexico, 64460
Instituto Nacional de Enfermedades Respiratorias
Mexico City, Mexico, 14080
Spain
Universitario Zaragoza - Hospital Clinico
Zaragoza, Spain, 50009
United Kingdom
North Hampshire Hospital
Hampshire, United Kingdom, RG24 9NA
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS97TF
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU

Sponsors and Collaborators

Cook

MED Institute, Incorporated

William Cook

William Cook Europe

Cook Ireland, Ltd.

Investigators

Principal Investigator:

R.W. Gunther, Prof.

Klinik Fur Radiologische Diagnostik Universitaetklinikum der RWTH Aachen

More Information

No publications provided

Responsible Party:	William Cook Europe ( Michael Seest )
Study ID Numbers:	05-507, 110006
Study First Received:	September 14, 2005
Last Updated:	May 5, 2009
ClinicalTrials.gov Identifier:	NCT00470626 History of Changes
Health Authority:	Mexico: Federal Commission for Sanitary Risks Protection; Australia: Department of Health and Ageing Therapeutic Goods Administration; Germany: Ethics Commission; Spain: Spanish Agency of Medicines

Keywords provided by Cook:

Pulmonary Embolism
Venous Thromboembolism
Inferior Vena Cava Filter
IVC
PE

Study placed in the following topic categories:

Kava
Embolism and Thrombosis
Pulmonary Embolism
Respiratory Tract Diseases
Embolism

Lung Diseases
Vascular Diseases
Venous Thromboembolism
Thrombosis
Thromboembolism

Additional relevant MeSH terms:

Embolism and Thrombosis
Pulmonary Embolism
Respiratory Tract Diseases
Embolism
Lung Diseases

Vascular Diseases
Cardiovascular Diseases
Venous Thromboembolism
Thrombosis
Thromboembolism

ClinicalTrials.gov processed this record on July 02, 2009