ODEN Trial: Option vs. Denali IVC Filters
Stopped early · Not applicable
Conditions studied: Venous Thromboembolism
In brief
This research study is a prospective randomized trial evaluating the relative safety of two inferior vena cava (IVC) filters used to prevent the migration of potentially dangerous deadly blood clots from the legs to the lung in patients who cannot take blood thinners. All eligible patients will have been ordered to have a IVC filter placed by their primary medical team and filters will be placed in these patients whether or not they wish to participate in this trial as part of standard of care. The investigators will follow up with patients 30 days after IVC filter placement and ask them to come back for filter removal if medically appropriate. If removal is not medically appropriate in 30 days, the investigators will attempt to schedule removal every 30 days after initial placement. Primary outcome measures will be IVC filter complications such as filter penetration through the IVC wall and into other organs, filter tilt, filter migration, filter fracture and clots formed within the filter. All of these are reported complications of all IVC filters. The research also aims to improve the standard of care for IVC filter patient follow up as the FDA and Society of Interventional Radiology recommend that IVC filters be removed as soon as it is safe to do so. Hypothesis: The investigators hypothesize that there is no significant difference in efficacy and complication rate between the Option and the Denali filter.
Key facts
- Study ID
- NCT02201277
- Run by
- University of California, San Francisco
- People needed
- 45
- Starts
- 2014-05-27
- Expected to finish
- 2018-04-27
- Last updated by the study team
- 2019-09-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients scheduled for IVC filter placement at UCSF Moffitt, Mission Bay and Mount Zion hospitals Interventional Radiology
- 18+
You may not qualify if…
- Necessity of permanent IVC filter.
- Genetic or physical abnormalities of the inferior vena cava
- Circumstances that in the opinion of the primary investigator, patient would be a poor candidate either due to complications in medical condition or lack of ability for follow up.
Where it is running
- UCSF Medical Center — San Francisco, California, United States
Full record on ClinicalTrials.gov
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