Failed Retrieval of Inferior Vena Cava (IVC) Filters: Long-Term Outcomes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Bayside Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00163956
First received: September 12, 2005
Last updated: October 3, 2006
Last verified: September 2005
  Purpose

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
DVT
PE

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Failed Retrieval of Inferior Vena Cava (IVC) Filters: Long-Term Outcomes

Further study details as provided by Bayside Health:

Estimated Enrollment: 20
Study Start Date: August 2005
Estimated Study Completion Date: December 2010
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • na

Exclusion Criteria:

  • na
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163956

Contacts
Contact: Stuart Lyon, MBBS FRANZCR 61 3 9276 2000 ext 3606 s.lyon@alfred.org.au
Contact: Helen Kavnoudias, PhD 61 3 9276 2000 ext 3606 h.kavnoudias@alfred.org.au

Locations
Australia, Victoria
Radiology Department, The Alfred Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Stuart Lyon, MBBS RANZCR    613 9276 2000 ext 3606    s.lyon@alfred.org.au   
Contact: Helen Kavnoudias, PhD    613 9276 2000 ext 3606    h.kavnoudias@alfred.org.au   
Principal Investigator: Stuart Lyon, MBBS RANZCR         
Sponsors and Collaborators
Bayside Health
Investigators
Principal Investigator: Stuart Lyon, MBBS RANZCR Bayside Health
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00163956     History of Changes
Other Study ID Numbers: AlfRad2005-1
Study First Received: September 12, 2005
Last Updated: October 3, 2006
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Bayside Health:
IVC filters
failed retrieval

ClinicalTrials.gov processed this record on October 23, 2014