ODEN Trial: Option vs. Denali IVC Filters

NCT02201277 | Terminated Results FDA Device

• 1 other identifier: UCSF 14-13307
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

IVC; IVC Filter; Filter; Option; Denali; filter tilt; filter migration; filter fracture; filter thrombus; filter penetration

Outcome Measures

Primary Outcomes (1)

• IVC: Filter Penetration

  Using imaging analysis, patients will resume their standard care as normal but be encouraged to come back in 30 days for imaging followup and removal. other than that we will look at all available CT and xray imaging that clearly shows the filter and IVC vessel walls. We will count how many participants have penetration of the IVC greater than 3mm and the number of days since placement at imaging timepoints. The number of struts or hooks per filter with penetration will also be recorded.

  in dwelling time in 1 day after filter insertion up to 3 years.

Secondary Outcomes (7)

• Computerized Tomography (CT) Studies With IVC Penetration

  0-1733 days

• Number of Participants With IVC Filter Migration

  30 days

• IVC Filter Tilt

  0-365 days post placement until project closure or patient endpoint reached

• IVC Filter Fracture

  30 days

• IVC Filter Clot

  30 days

Study Arms (2)

Denali

EXPERIMENTAL

Denali IVC Filter

Device: Filter Placed

Option

EXPERIMENTAL

Option Elite IVC Filter

Device: Filter Placed

Interventions

Filter Placed DEVICE

Denali; Option

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for IVC filter placement at UCSF Moffitt, Mission Bay and Mount Zion hospitals Interventional Radiology

You may not qualify if:

• Necessity of permanent IVC filter.
• Genetic or physical abnormalities of the inferior vena cava
• Circumstances that in the opinion of the primary investigator, patient would be a poor candidate either due to complications in medical condition or lack of ability for follow up.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Medical Center

San Francisco, California, 94143, United States

Location

Related Publications (1)

• Woodcock A, Campbell I, Collins JV, Hanson P, Harvey J, Corris P, Johnston ID. Bronchoscopy and infection control. Lancet. 1989 Jul 29;2(8657):270-1. doi: 10.1016/s0140-6736(89)90451-0. No abstract available.

  PMID: 2569071 BACKGROUND

Related Links

• ucsf radiology home page

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

The ODEN trial was initially powered to observe differences between the two filter types after 75 of each filter were to be placed. Due to the opening of the PRESERVE trial and slightly lower than expected enrollment, the trial was terminated early.

Results Point of Contact

• Title: Maureen Kohi, MD
• Organization: University of California, San Francisco, Interventional Radiology

maureen.kohi@ucsf.edu

(415) 353-1300

Study Officials

• Maureen P Kohi, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: analysis of the imaging data will be masked and filter type and PHI will be redacted so the radiologist assessor will not know which patients receive either the option or denali..
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 28, 2014
• Study Start: May 27, 2014
• Primary Completion: April 13, 2018
• Study Completion: April 27, 2018
• Last Updated: September 12, 2019
• Results First Posted: September 12, 2019

Record last verified: 2019-08

Locations

US (1)