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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00470626
Registration number
NCT00470626
Ethics application status
Date submitted
14/09/2005
Date registered
8/05/2007
Date last updated
25/01/2016
Titles & IDs
Public title
Celect Vena Cava Filter Clinical Trial
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Scientific title
Prospective Study of the Cook Celect Filter, Including Permanent and Retrievable Use
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Secondary ID [1]
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110006, GTMX
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Secondary ID [2]
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05-507
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Embolism
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Venous Thromboembolism
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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Clotting disorders
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Respiratory
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Celect Vena Cava Filter
Experimental: 1 - Vena Cava Filter
Treatment: Devices: Celect Vena Cava Filter
Effective filtration of inferior vena cava blood to prevent thromboembolism.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Major Adverse Event
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Assessment method [1]
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Composite Major Adverse Event includes hemorrhage, perforation, pulmonary embolism, procedure-related or device-related death, occlusion, significant migration and filter fracture.
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Timepoint [1]
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up to 12 months
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Secondary outcome [1]
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Successful Retrieval
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Assessment method [1]
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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).
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Timepoint [1]
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up to 12 months
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Secondary outcome [2]
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Mean Time to Retrieval Attempt
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Assessment method [2]
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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.
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Timepoint [2]
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up to 12 months
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2009
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Sample size
Target
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Accrual to date
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Final
129
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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3181 - Melbourne
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Recruitment outside Australia
Country [1]
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Germany
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State/province [1]
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Aachen
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Country [2]
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Mexico
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State/province [2]
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Mexico City
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Country [3]
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Mexico
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State/province [3]
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Monterrey
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Country [4]
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Spain
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State/province [4]
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Zaragoza
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Country [5]
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United Kingdom
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State/province [5]
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Hampshire
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Country [6]
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United Kingdom
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State/province [6]
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Leeds
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Country [7]
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United Kingdom
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State/province [7]
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Cook Group Incorporated
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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MED Institute, Incorporated
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Address [1]
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Country [1]
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Other collaborator category [2]
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Commercial sector/industry
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Name [2]
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William Cook Australia
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Address [2]
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Country [2]
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Other collaborator category [3]
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Commercial sector/industry
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Name [3]
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William Cook Europe
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Address [3]
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Country [3]
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Other collaborator category [4]
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Commercial sector/industry
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Name [4]
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Cook Ireland, Ltd.
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Address [4]
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Country [4]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00470626
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Trial related presentations / publications
Lyon SM, Riojas GE, Uberoi R, Patel J, Lipp ME, Plant GR, De Gregorio MA, Gunther RW, Voorhees WD, McCann-Brown JA. Short- and long-term retrievability of the Celect vena cava filter: results from a multi-institutional registry. J Vasc Interv Radiol. 2009 Nov;20(11):1441-8. doi: 10.1016/j.jvir.2009.07.038.
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Public notes
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Contacts
Principal investigator
Name
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R.W. Gunther, Prof.
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Address
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Klinik Fur Radiologische Diagnostik Universitaetklinikum der RWTH Aachen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Lyon SM, Riojas GE, Uberoi R, Patel J, Lipp ME, Pl...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT00470626
Download to PDF