Predicting the Safety and Effectiveness of Inferior Vena Cava Filters

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

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

Exclusion Criteria:

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Haraldur Bjarnason, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Haraldur Bjarnason, M.D.

Closed for enrollment

More information

Publications

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