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Completed

NCT Number: NCT04785313

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

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.

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Key information

Conditions

Vena Cava Thrombosis Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Saint-Etienne

Saint-Etienne, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Retrievable Inferior Vena Cava Filters (IVCF)

Biological

Analysis anatomopathology of Retrievable Inferior Vena Cava Filters (IVCF) (ALN CF model).

Demographics data collection

Other

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 5, 2021
Registry last updated
Mar 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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