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Celect Vena Cava Filter Clinical Trial

This study is ongoing, but not recruiting participants.

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

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




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