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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04785313
Enrollment
85
Registered
2021-03-05
Start date
2015-01-15
Completion date
2015-04-30
Last updated
2021-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vena Cava Thrombosis

Keywords

Inferior Vena Cava Filters, Mechanism, Retrievable, Deep Venous Thrombosis, Pathological Evolution, pulmonary embolism

Brief summary

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.

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.

Interventions

BIOLOGICALRetrievable Inferior Vena Cava Filters (IVCF)

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

OTHERDemographics 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.

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
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.3 monthsPresence 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

MeasureTime frameDescription
Correlation between presence of vascular wall fragments and venous thromboembolism event or death within 3 months following removal.3 monthsMeasured by anatomopathology analysis of the Inferior Vena Cava Filters (IVCF).
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)3 monthsTilt 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026