Using a Novel Algorithm to Improve the Retrieval Rate of Inferior Vena Cava Filters (iRetrieve Study)
NCT02160964 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1786
Last updated 2015-03-19
Summary
Since 2003, that the first retrievable IVC filter was introduced in the U.S,improvements have been made in the filter design to resolve problems of structural integrity and increase the ability to remove the filter after longer periods of time.The FDA issued a communication in August 2010 advising physicians to remove retrievable filters whenever possible and updated that letter again in May 2014 due to concerns that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient's risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.
Conditions
- Venous Thromboembolism,
- Pulmonary Embolism,
- Deep Vein Thrombosis,
Sponsors & Collaborators
-
Heart and Vascular Outcomes Research Institute
lead OTHER
Principal Investigators
-
Uchenna Onyeachom · Heart and Vascular Outcomes Research Institute
-
John Rectenwald, MD · University Of Michigan Health System, Ann Arbor
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-05-31
- Primary Completion
- 2016-07-31
- Completion
- 2017-01-31
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