Skip to Content

M01482: PRESERVE; Inferior Vena Cava Filters

Predicting the Safety and Effectiveness of Inferior Vena Cava Filters

Objective

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

Phase: N/A

Learn More

ClinicalTrials.Gov

IRB Protocol Number
M01482

Clinical Trial Categories

  • Cardiology
How to Participate

Darla Howard

864-560-1042

Was this page helpful?

Yes
No

Thank you for your feedback!

Thank you for your feedback and helping us to improve our website.
There will be no additional response.

Upcoming Events

  • Oct
    17
    Wednesday
    11:30 AM - 1:00 PM
    Heart Matters is a support group for women living with or at risk of heart disease.
  • Oct
    17
    Wednesday
    11:30 AM - 1:30 PM
    "Table for Two - Daytime" is a breastfeeding support group for new moms and their baby that meets on Wednesday's at lunchtime.

News & Highlights

Stay Connected!

Get the latest news on the health topics that matter most to you.

Sign up