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ODEN Trial: Option vs. Denali IVC Filters

NCT02201277 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2019-09-12

Study results available
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Summary

This research study is a prospective randomized trial evaluating the relative safety of two inferior vena cava (IVC) filters used to prevent the migration of potentially dangerous deadly blood clots from the legs to the lung in patients who cannot take blood thinners. All eligible patients will have been ordered to have a IVC filter placed by their primary medical team and filters will be placed in these patients whether or not they wish to participate in this trial as part of standard of care. The investigators will follow up with patients 30 days after IVC filter placement and ask them to come back for filter removal if medically appropriate. If removal is not medically appropriate in 30 days, the investigators will attempt to schedule removal every 30 days after initial placement.

Primary outcome measures will be IVC filter complications such as filter penetration through the IVC wall and into other organs, filter tilt, filter migration, filter fracture and clots formed within the filter. All of these are reported complications of all IVC filters.

The research also aims to improve the standard of care for IVC filter patient follow up as the FDA and Society of Interventional Radiology recommend that IVC filters be removed as soon as it is safe to do so.

Hypothesis:

The investigators hypothesize that there is no significant difference in efficacy and complication rate between the Option and the Denali filter.

Conditions

  • Venous Thromboembolism

Interventions

DEVICE

Filter Placed

Sponsors & Collaborators

Principal Investigators

  • Maureen P Kohi, M.D. · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-27
Primary Completion
2018-04-13
Completion
2018-04-27
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02201277 on ClinicalTrials.gov