Clinical trial NCT04785313: Anatomopathological Analysis and Clinical Evolution After Radiological Removal of Retrievable Vena Cava Filters
Official title: Anatomopathological Analysis and Clinical Evolution After Radiological Removal of Retrievable Vena Cava Filters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vena Cava Thrombosis
Keywords: Inferior Vena Cava Filters
Mechanism
Retrievable
Deep Venous Thrombosis
Pathological Evolution
pulmonary embolism
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: 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.
timeFrame: 3 months
Secondary outcomes:
measure: Correlation between presence of vascular wall fragments and venous thromboembolism event or death within 3 months following removal.
timeFrame: 3 months
measure: 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)
timeFrame: 3 months
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Fabrice-Guy BARRAL, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: