NCT02160964

Brief Summary

Since 2003, that the first retrievable IVC filter was introduced in the U.S,improvements have been made in the filter design to resolve problems of structural integrity and increase the ability to remove the filter after longer periods of time.The FDA issued a communication in August 2010 advising physicians to remove retrievable filters whenever possible and updated that letter again in May 2014 due to concerns that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient's risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,786

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
11 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

1.2 years

First QC Date

June 7, 2014

Last Update Submit

March 18, 2015

Conditions

Venous Thromboembolism,Pulmonary Embolism,Deep Vein Thrombosis,

Keywords

Inferior Vena Cava

Outcome Measures

Primary Outcomes (1)

  • Filter retrieval rate

    24 Months

Secondary Outcomes (1)

  • Absence of major adverse event

    24 Months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participating study centers will enroll patients and enter data in the web-based platform that include demographics, clinical features, and clinical pathway

You may qualify if:

  • Data obtained in line with good clinical practice, applicable laws and regulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Venous ThromboembolismPulmonary EmbolismVenous Thrombosis

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolismThrombosis

Study Officials

  • Uchenna Onyeachom

    Heart and Vascular Outcomes Research Institute

    STUDY DIRECTOR

  • John Rectenwald, MD

    University Of Michigan Health System, Ann Arbor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Uchenna N Onyeachom

CONTACT

uonyeachom@hvori.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2014

First Posted

June 11, 2014

Study Start

May 1, 2015

Primary Completion

July 1, 2016

Study Completion

January 1, 2017

Last Updated

March 19, 2015

Record last verified: 2015-03