Celect Vena Cava Filter Clinical Trial

This study has been completed.
Sponsor:
Collaborators:
MED Institute, Incorporated
William Cook Australia
William Cook Europe
Cook Ireland, Ltd.
Information provided by:
Cook
ClinicalTrials.gov Identifier:
NCT00470626
First received: September 14, 2005
Last updated: April 12, 2010
Last verified: April 2010
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Study of the Cook Celect Filter, Including Permanent and Retrievable Use

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • Major Adverse Event [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
    Composite Major Adverse Event includes hemorrhage, perforation, pulmonary embolism, procedure-related or device-related death, occlusion, significant migration and filter fracture.


Secondary Outcome Measures:
  • Successful Retrieval [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    Retrieval attempt describes a procedure in which a physician tried to remove a filter from a patient. A decision to remove a filter was made after determining that the patient no longer required the filter. Retrieval attempts were either successful (i.e., the filter was removed) or unsuccessful (i.e., the filter could not be removed and remained in the patient as a permanent device).

  • Mean Time to Retrieval Attempt [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]

    Mean time to retrieval describes the average time filters were in place in the study group before a retrieval attempt was made.

    A retrieval attempt describes a procedure in which a physician tried to remove a filter from a patient. The mean time to retrieval describes the average time filters were in place before a retrieval attempt was made.



Enrollment: 129
Study Start Date: November 2005
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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:

  • 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 return for clinical imaging follow-up at 1, 3, 6, and 12 months.
  • 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:

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Instituto Nacional de Enfermedades Respiratorias
Mexico City, Mexico, 14080
Hospital Universitario de Nuevo Leon
Monterrey, Mexico, 64460
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 Australia
William Cook Europe
Cook Ireland, Ltd.
Investigators
Principal Investigator: R.W. Gunther, Prof. Klinik Fur Radiologische Diagnostik Universitaetklinikum der RWTH Aachen
  More Information

Publications:
Responsible Party: Michael Seest, William Cook Europe
ClinicalTrials.gov Identifier: NCT00470626     History of Changes
Other Study ID Numbers: 05-507, 110006, GTMX
Study First Received: September 14, 2005
Results First Received: February 3, 2010
Last Updated: April 12, 2010
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

Additional relevant MeSH terms:
Thromboembolism
Embolism
Venous Thromboembolism
Venous Thrombosis
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 02, 2014