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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00163956
Registration number
NCT00163956
Ethics application status
Date submitted
12/09/2005
Date registered
14/09/2005
Date last updated
4/10/2006
Titles & IDs
Public title
Failed Retrieval of Inferior Vena Cava (IVC) Filters: Long-Term Outcomes
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Scientific title
Failed Retrieval of Inferior Vena Cava (IVC) Filters: Long-Term Outcomes
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Secondary ID [1]
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AlfRad2005-1
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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:
DVT
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0
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PE
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0
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key inclusion criteria
* na
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Minimum age
18
Years
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Maximum age
80
Years
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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
* na
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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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
1/08/2005
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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
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Radiology Department, The Alfred - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Bayside Health
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The inferior vena cava (IVC) is a large vein that enters the bottom part of the heart. Venous blood from the lower portion of the body drains into the IVC. The IVC then returns blood back to the heart. An IVC filter is placed to help prevent the blood clots moving from the legs to the heart or lung. The idea behind using a filter in the IVC is to capture potential fatal pulmonary emboli at an anatomical location where they may pose less risk for the patient. Early filters, 1960's and 70's were, remained in the vein permanently. More recently, temporary or retrievable filters have been developed and are being widely used. Complications have been demonstrated with long-term placement of IVC filters. In a randomised study it was found that that patients with IVC filter placement had greater than three times the incidence of recurrent deep vein thrombosis (DVT) compared to their control population at two years. Blockage of the vein, recurrent pulmonary emboli, filter penetration and filter fragmentation have all been described. With the advent of retrievable filters (filters that can be place temporarily and then removed at a later date) there has been renewed popularity for placement of temporary filters. To our knowledge, no one has yet to follow the population of intended temporary IVC filters, who undergo failed retrieval, and consequently end up with a permanent IVC filter. We plan to prospectively enrol 40 Alfred patients who have undergone a temporary IVC filter placement and subsequently have had failed IVC filter retrieval. Our aim is to evaluate the long term outcomes for patients with failed IVC retrieval. Specifically we will determine the risk, due to failed filter retrieval, of: * IVC stenosis * IVC occlusion * Development of DVT and * analyse the clinical outcomes (symptoms), their prevalence and their distribution Patients will receive routine care and their data will be analysed annually as collected. The follow-up period is indefinite and will be at the discretion of the treating doctor.
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Trial website
https://clinicaltrials.gov/study/NCT00163956
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Stuart Lyon, MBBS RANZCR
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Address
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Bayside Health
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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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Stuart Lyon, MBBS FRANZCR
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Address
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Country
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Phone
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61 3 9276 2000
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Fax
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Email
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[email protected]
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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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00163956
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