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

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Completed

Conditions

Vena Cava Thrombosis

Treatments

Other: Demographics data collection
Biological: Retrievable Inferior Vena Cava Filters (IVCF)

Study type

Observational

Funder types

Other

Identifiers

NCT04785313
IRBN422021/CHUSTE

Details and patient eligibility

About

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.

Full 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.

Enrollment

85 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

85 participants in 1 patient group

Retrievable Inferior Vena Cava Filters (IVCF)
Description:
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.
Treatment:
Biological: Retrievable Inferior Vena Cava Filters (IVCF)
Other: Demographics data collection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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