Anatomopathological Analysis and Clinical Evolution After Radiological Removal of Retrievable Vena Cava Filters

March 2, 2021 updated by: Centre Hospitalier Universitaire de Saint Etienne

Pulmonary embolism (PE) is a common pathology causing significant morbidity and mortality. It is usually secondary to migration through the inferior vena cava (IVC) of a formed thrombus in the veins of the lower limbs or pelvis. The inferior vena cava filter (IVCF) is a medical device whose purpose is to prevent thrombus migration from the veins of the legs and pelvis to the pulmonary arteries, thus preventing the occurrence of Pulmonary embolism (PE).

There is no data on the interactions of Retrievable inferior vena cava filters (IVCF) with the inferior vena cava (intrafilter thrombi, insertion through the venous wall) although it may modify the evolution after IVCF retrievable.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main objective of this study is to determine whether the presence of intrafilter thrombi identified by anatomopathology at the time of inferior vena cava filters (IVCF) retrievable was associated with the occurrence of a venous thromboembolism event within 3 months following removal.

Study Type

Observational

Enrollment (Actual)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Étienne, France
        • CHU Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a Inferior Vena Cava Filters (IVCF) placed because of temporary contraindication to curative anticoagulation and that was been removed by the radiology department at the University Hospital of Saint-Etienne, between January 1, 2010 and December 31, 2014. All the Inferior Vena Cava Filters (IVCF) were been sent for histological examination.

Description

Inclusion Criteria:

  • Patients with a Inferior Vena Cava Filters (IVCF) placed because of temporary contraindication to curative anticoagulation and that was removed by the radiology department at the University Hospital of Saint-Etienne

Exclusion Criteria:

  • Patients included in the PREPIC 2 study
  • Patients whose basement filter had not been removed (difficult removal with surgery, no indication for removal).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrievable Inferior Vena Cava Filters (IVCF)
The population study includes patients with a Retrievable Inferior Vena Cava Filters (IVCF) placed because of temporary contraindication to curative anticoagulation and that was been removed by the radiology department at the University Hospital of Saint-Etienne, between January 1, 2010 and December 31, 2014. All the Inferior Vena Cava Filters (IVCF) were been sent for histological examination.
Biological: Retrievable Inferior Vena Cava Filters (IVCF)
Analysis anatomopathology of Retrievable Inferior Vena Cava Filters (IVCF) (ALN CF model).
Other: Demographics data collection
Demographics data : age, gender, thromboembolic risk factors, Retrievable Inferior Vena Cava Filters (IVCF) (indication, dates of insertion and removal), and anticoagulant management during the period with filter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between presence of intrafilter thrombi identified by anatomopathologist at the time of retrievable inferior vena cava filters (IVCF) and the occurrence of a venous thromboembolism event within 3 months following removal.
Time Frame: 3 months

Presence of intrafilter thrombi is measure by anatomopathology analysis of the Inferior Vena Cava Filters (IVCF).

Venous thromboembolism events are either deep venous thrombosis (DVT) of the lower limbs (diagnosed by Doppler ultrasonography of the lower limbs) or pulmonary embolism (PE) (diagnosed by chest angio-computed tomography).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between presence of vascular wall fragments and venous thromboembolism event or death within 3 months following removal.
Time Frame: 3 months
Measured by anatomopathology analysis of the Inferior Vena Cava Filters (IVCF).
3 months
Correlation between a high tilt of the Inferior Vena Cava Filters (IVCF) and the occurrence of thromboembolic events within the 3 months following the removal of the Inferior Vena Cava Filters (IVCF)
Time Frame: 3 months

Tilt was numerically calculated (from 1 to 20) using the Carestream picture archiving communication system (PACS®) for the majority of the patients treated since 2012 and using a protractor on radiological and light boxes films for patients treated 2010 and 2011 (not recorded on the PACS®).

High Tilt is Tilt > 15.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Fabrice-Guy BARRAL, MD PhD, CHU Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2015

Primary Completion (Actual)

April 30, 2015

Study Completion (Actual)

April 30, 2015

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

March 2, 2021

First Posted (Actual)

March 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 5, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBN422021/CHUSTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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