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

Vena Cava Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04785313
• Other study ID #: IRBN422021/CHUSTE
• Status: Completed
• Start date: January 15, 2015
• Est. completion date: April 30, 2015

Study information

• Verified date: February 2021
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: April 30, 2015
• Est. primary completion date: April 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Thrombosis
• Vena Cava Thrombosis

Intervention

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.

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	Correlation between presence of vascular wall fragments and venous thromboembolism event or death within 3 months following removal.	Measured by anatomopathology analysis of the Inferior Vena Cava Filters (IVCF).	3 months
Secondary	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)	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