Predicting the Safety and Effectiveness of Inferior Vena Cava Filters
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-001860
NCT ID: NCT02381509
Sponsor Protocol Number: M01482
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 |
|
More information
Publications
Publications are currently not available