Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE)
Diseases of the Cardiovascular System
What is the purpose of this trial?
PRESERVE is a multi-center, prospective, open-label, non-randomized investigation of commercially available IVC filters from 7 manufacturers placed in subjects for the prevention of pulmonary embolism (PE). This study will enroll approximately 2,100 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. The primary objective of this investigational device exemption (IDE) clinical investigation is to evaluate the safety and effectiveness of the commercially available IVC filters (retrievable and permanent) in subjects with clinical need for mechanical prophylaxis of PE with an IVC filter.
- Ages18 years and older
- Trial withNew England Research Institute
- Start Date03/22/2016
- End Date04/30/2018
- Last Updated02/22/2018
- Study HIC#1508016319