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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - Composite Major Adverse Event includes hemorrhage, perforation, pulmonary embolism, procedure-related or device-related death, occlusion, significant migration and filter fracture.
Timepoint [1] 0 0
up to 12 months
Secondary outcome [1] 0 0
Successful Retrieval - 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).
Timepoint [1] 0 0
up to 12 months
Secondary outcome [2] 0 0
Mean Time to Retrieval Attempt - 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.
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
Gender
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
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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.
Trial website
https://clinicaltrials.gov/show/NCT00470626
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

Summary results
Other publications