Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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
Query!
Scientific title
Prospective Study of the Cook Celect Filter, Including Permanent and Retrievable Use
Query!
Secondary ID [1]
0
0
110006, GTMX
Query!
Secondary ID [2]
0
0
05-507
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Pulmonary Embolism
0
0
Query!
Venous Thromboembolism
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Blood
0
0
0
0
Query!
Clotting disorders
Query!
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Major Adverse Event
Query!
Assessment method [1]
0
0
Composite Major Adverse Event includes hemorrhage, perforation, pulmonary embolism, procedure-related or device-related death, occlusion, significant migration and filter fracture.
Query!
Timepoint [1]
0
0
up to 12 months
Query!
Secondary outcome [1]
0
0
Successful Retrieval
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
up to 12 months
Query!
Secondary outcome [2]
0
0
Mean Time to Retrieval Attempt
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
up to 12 months
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
N/A
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/11/2005
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/03/2009
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
129
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
The Alfred Hospital - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
3181 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
Germany
Query!
State/province [1]
0
0
Aachen
Query!
Country [2]
0
0
Mexico
Query!
State/province [2]
0
0
Mexico City
Query!
Country [3]
0
0
Mexico
Query!
State/province [3]
0
0
Monterrey
Query!
Country [4]
0
0
Spain
Query!
State/province [4]
0
0
Zaragoza
Query!
Country [5]
0
0
United Kingdom
Query!
State/province [5]
0
0
Hampshire
Query!
Country [6]
0
0
United Kingdom
Query!
State/province [6]
0
0
Leeds
Query!
Country [7]
0
0
United Kingdom
Query!
State/province [7]
0
0
Oxford
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Cook Group Incorporated
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
MED Institute, Incorporated
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Commercial sector/Industry
Query!
Name [2]
0
0
William Cook Australia
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Other collaborator category [3]
0
0
Commercial sector/Industry
Query!
Name [3]
0
0
William Cook Europe
Query!
Address [3]
0
0
Query!
Country [3]
0
0
Query!
Other collaborator category [4]
0
0
Commercial sector/Industry
Query!
Name [4]
0
0
Cook Ireland, Ltd.
Query!
Address [4]
0
0
Query!
Country [4]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00470626
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
R.W. Gunther, Prof.
Query!
Address
0
0
Klinik Fur Radiologische Diagnostik Universitaetklinikum der RWTH Aachen
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00470626
Download to PDF