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

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (Other)
• Overall Status: Completed
• CT.gov ID: NCT04785313
• Collaborator: (none)
• Enrollment: 85
• Location: 1
• Actual Duration (Months): 3.4
• Patients Per Site Per Month: 24.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vena Cava Thrombosis	Biological: Retrievable Inferior Vena Cava Filters (IVCF); Other: Demographics data collection

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 85 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Anatomopathological Analysis and Clinical Evolution After Radiological Removal of Retrievable Vena Cava Filters
• Actual Study Start Date: Jan 15, 2015
• Actual Primary Completion Date: Apr 30, 2015
• Actual Study Completion Date: Apr 30, 2015

Arms and Interventions

Arm

Intervention/Treatment

Retrievable Inferior Vena Cava Filters (IVCF) 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.

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.

Outcome Measures

Primary Outcome Measures

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. [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 Outcome Measures

1. Correlation between presence of vascular wall fragments and venous thromboembolism event or death within 3 months following removal. [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) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Saint-Etienne	Saint-Étienne		France

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Saint Etienne

Investigators

• Principal Investigator: Fabrice-Guy BARRAL, MD PhD, CHU Saint-Etienne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT04785313
• Other Study ID Numbers: IRBN422021/CHUSTE
• First Posted: Mar 5, 2021
• Last Update Posted: Mar 5, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Universitaire de Saint Etienne: Inferior Vena Cava Filters; Mechanism; Retrievable; Deep Venous Thrombosis; Pathological Evolution; pulmonary embolism
• Additional relevant MeSH terms: Thrombosis

Study Results

No Results Posted as of Mar 5, 2021