Celect Vena Cava Filter Clinical Trial - Full Text View

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

MedlinePlus related topics:

Pulmonary Embolism

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	85
Study Start Date:	November 2005
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 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

Responsible Party:	William Cook Europe ( Michael Seest )
Study ID Numbers:	05-507-01, 110006
First Received:	September 14, 2005
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00470626
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; Ireland: Irish Medicines Board

Keywords provided by Cook:

Pulmonary Embolism

Venous Thromboembolism

Inferior Vena Cava Filter

IVC

PE

Study placed in the following topic categories:

Embolism and Thrombosis

Pulmonary Embolism

Respiratory Tract Diseases

Embolism

Lung Diseases

Vascular Diseases

Venous Thromboembolism

Thrombosis

Thromboembolism

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 05, 2008

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