The study is a multi-center, prospective, open-label, non-randomized investigation of commercially available IVC filters from 6 manufacturers placed in subjects for the prevention of PE. This study will enroll approximately 1,800 IVC filter subjects at up to 60 sites in the US. All treated subjects will be evaluated at procedure, 3-months, 6-months (phone), 12-months, 18-months (phone), and 24-months post-procedure. All subjects in whom the IVC filter is removed will be followed for 1-month post-retrieval. All subjects who are considered a treatment failure at time of procedure will be followed for 1-month post-procedure. Mandated follow-up imaging will be performed at 3 months (plain film) and 12 and 24 months (contrast or non-contrast abdominal CT). In addition, clinical visits with physical exam will be performed at 3 months, 12 months and 24 months.
There will be 300 subjects enrolled for each IVC filter from participating manufacturers. Once the subject enrollment has been reached per IVC filter, enrollment will be closed for further enrollment of subjects using that particular IVC filter.
For more information visit Clinicaltrials.gov NCT02381509