Vena Cava ThrombosisNCT04785313
Anatomopathological Analysis and Clinical Evolution After Radiological Removal of Retrievable Vena Cava Filters
An observational study of Vena Cava Thrombosis, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vena Cava Thrombosis
- What is being tested?
- Retrievable Inferior Vena Cava Filters (IVCF) and Demographics data collection
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2015to 30 Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients included in the PREPIC 2 study
- Patients whose basement filter had not been removed (difficult removal with surgery, no indication for removal).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Vena Cava Thrombosis
- Being tested
- Retrievable Inferior Vena Cava Filters (IVCF), Demographics data collection
- Keywords
- Inferior Vena Cava Filters, Mechanism, Retrievable, Deep Venous Thrombosis, Pathological Evolution, pulmonary embolism
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrievable Inferior Vena Cava Filters (IVCF)Biological
Analysis anatomopathology of Retrievable Inferior Vena Cava Filters (IVCF) (ALN CF model).
Demographics data collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Retrievable Inferior Vena Cava Filters (IVCF); Other: Demographics data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (2)
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).
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start15 Jan 2015
- Primary completion30 Apr 2015
- Study completion30 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vena Cava ThrombosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice-Guy BARRAL, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785313
- Sponsor's protocol ID
- IRBN422021/CHUSTE
- Status last verified
- Feb 2021
- First submitted
- 26 Feb 2021
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomopathological Analysis and Clinical Evolution After Radiological Removal of Retrievable Vena Cava Filters
- ClinicalTrials.gov ID
- NCT04785313
- Acronym / sponsor ID
- IRBN422021/CHUSTE
- Conditions
- Vena Cava Thrombosis
- Keywords
- Inferior Vena Cava Filters, Mechanism, Retrievable, Deep Venous Thrombosis, Pathological Evolution, pulmonary embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 15 Jan 2015 (actual)
- Primary completion
- 30 Apr 2015 (actual)
- Study completion
- 30 Apr 2015 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrievable Inferior Vena Cava Filters (IVCF) | – | Biological: Retrievable Inferior Vena Cava Filters (IVCF), Other: Demographics data collectionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Patients included in the PREPIC 2 study
- Patients whose basement filter had not been removed (difficult removal with surgery, no indication for removal).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrievable Inferior Vena Cava Filters (IVCF)Analysis anatomopathology of Retrievable Inferior Vena Cava Filters (IVCF) (ALN CF model). | Biological | Retrievable Inferior Vena Cava Filters (IVCF) |
| Demographics data collectionDemographics 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. | Other | Retrievable Inferior Vena Cava Filters (IVCF) |
Primary outcome
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.
Time frame: 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).
2 secondary outcomes
Correlation between presence of vascular wall fragments and venous thromboembolism event or death within 3 months following removal.
Time frame: 3 months
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)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice-Guy BARRAL, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vena Cava Thrombosis, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.