Predicting the Safety and Effectiveness of Inferior Vena Cava Filters
Overview
PRESERVE is a multi-center, prospective, open-label, non-randomized investigation of commercially available IVC filters from six manufacturers placed in subjects for the prevention of pulmonary embolism (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. 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.
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply.
- Male or Female, age 18 years or older;
- Requires IVC filter for prevention of pulmonary embolism (PE);
- Provide written informed consent and written HIPAA authorization prior to initiation of study procedures;
- Willing to comply with the specified follow-up
Key Exclusion Criteria
A patient will not be eligible for participation in this study if any of the following criteria apply.
- Subject is unable to participate in study evaluations pre- and post-treatment
- Known sensitivity to contrast or serious contrast reaction such as anaphylaxis for which premedication is known to be unsuccessful in alleviating symptoms