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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
Scientific title
Prospective Study of the Cook Celect Filter, Including Permanent and Retrievable Use
Secondary ID [1] 0 0
110006, GTMX
Secondary ID [2] 0 0
05-507
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Embolism 0 0
Venous Thromboembolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Major Adverse Event
Timepoint [1] 0 0
up to 12 months
Secondary outcome [1] 0 0
Successful Retrieval
Timepoint [1] 0 0
up to 12 months
Secondary outcome [2] 0 0
Mean Time to Retrieval Attempt
Timepoint [2] 0 0
up to 12 months

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2009
Sample size
Target
Accrual to date
Final
129
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Aachen
Country [2] 0 0
Mexico
State/province [2] 0 0
Mexico City
Country [3] 0 0
Mexico
State/province [3] 0 0
Monterrey
Country [4] 0 0
Spain
State/province [4] 0 0
Zaragoza
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Hampshire
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Leeds
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cook Group Incorporated
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
MED Institute, Incorporated
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
William Cook Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
William Cook Europe
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/industry
Name [4] 0 0
Cook Ireland, Ltd.
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
R.W. Gunther, Prof.
Address 0 0
Klinik Fur Radiologische Diagnostik Universitaetklinikum der RWTH Aachen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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

TypeCitations 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