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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A00915-38 | Other Identifier | Agence nationale de sécurité du médicament et des produits de santé |
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| Name | Class |
|---|---|
| Aln2b SARL | UNKNOWN |
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Migration of a thrombus in the pulmonary circulation is the leading cause of pulmonary embolism (PE). It can be prevented mechanically by implanting a vena cava filter (VCF) in the inferior vena cava. The implation of a VCF is indicated for patients with acute PE and a contraindication to anticoagulation, with an acute deep vein thrombosis (DVT) without PE and a contraindication to anticoagulation or with acute venous thromboembolism (less than 3 months) in whom an interventional gesture at hemorrhagic and thromboembolic risk contraindicates anticoagulation.
The purpose of this study is to describe the rates of implantation, removal and complications associated with the use of the optional ALN OATF VCF in current practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vena Cava Filter | Participants implanted with the vena cava filter OATF (ALN) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filter implantation | Device | Implantation of OATF ALN vena cava filter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Filter implantation | Rate of technical success of filter implantation | day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Filter removal | Rate of filter removal | up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients requiring a vena cave filter
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| Name | Affiliation | Role |
|---|---|---|
| Olivier PELLERIN, MD - PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP - Hôpital Européen Georges-Pompidou Paris, France | Paris | Île-de-France Region | 75908 | France |
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Two years after the last publication
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered.
Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement.
Processing of shared data must comply with European General Data Protection Regulation (GDPR).
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |