Failed Retrieval of Inferior Vena Cava (IVC) Filters: Long-Term Outcomes
|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 evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00163956|
Recruitment Status : Unknown
Verified September 2005 by Bayside Health.
Recruitment status was: Recruiting
First Posted : September 14, 2005
Last Update Posted : October 4, 2006
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.
|Condition or disease|
|Study Type :||Observational|
|Enrollment :||20 participants|
|Observational Model:||Defined Population|
|Observational Model:||Natural History|
|Official Title:||Failed Retrieval of Inferior Vena Cava (IVC) Filters: Long-Term Outcomes|
|Study Start Date :||August 2005|
|Study Completion Date :||December 2010|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163956
|Contact: Stuart Lyon, MBBS FRANZCR||61 3 9276 2000 ext firstname.lastname@example.org|
|Contact: Helen Kavnoudias, PhD||61 3 9276 2000 ext email@example.com|
|Radiology Department, The Alfred||Recruiting|
|Melbourne, Victoria, Australia, 3004|
|Contact: Stuart Lyon, MBBS RANZCR 613 9276 2000 ext 3606 firstname.lastname@example.org|
|Contact: Helen Kavnoudias, PhD 613 9276 2000 ext 3606 email@example.com|
|Principal Investigator: Stuart Lyon, MBBS RANZCR|
|Principal Investigator:||Stuart Lyon, MBBS RANZCR||Bayside Health|