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This prospective, observational, post-market study will be performed to collect patient-level data on the Celect Platinum Vena Cava Filter Sets and the Günther Tulip Vena Cava Filter Retrieval Set to confirm continued safety and performance of the devices throughout their expected lifetime and continued acceptability of the benefit:risk ratio. Additionally, the study intends to evaluate longer-term (i.e., up to 5 years) outcome data while the filter is indwelling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients indicated for the placement of a Celect Platinum Vena Cava Filter | Patients indicated for the placement of a Celect Platinum Vena Cava Filter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celect Platinum Vena Cava Filter | Device | Inferior vena cava filter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Filter-related primary endpoint (safety) | Freedom from major adverse events through 12 months (365 ± 30 days), defined as clinically significant IVC penetration, migration of filter (>2 cm)/filter components, filter fracture, embolization of filter or filter fragments to the heart or lungs, IVC thrombotic occlusion, symptomatic deep vein thrombosis while a filter is indwelling, access site complications with clinical sequelae, and procedure/device-related death. | Index procedure through 12-months post procedure |
| Filter-related primary endpoint (performance) | Performance: Technical placement success and freedom from symptomatic PE while a filter is indwelling through 12 months (365 ± 30 days).These values will be reported as aggregate. Technical placement success - Deployment of filter in a location suitable to provide sufficient mechanical protection against PE with no filter deformation, fracture, premature release, or clinical migration. | 12-months post procedure |
| Filter Retrieval-related primary endpoint | Freedom from major adverse events through 30 days post-procedure, defined as access site complications with clinical sequelae, and procedure/device-related death. | Through 30-days post procedure |
| Filter Retrieval-related primary endpoint | Technical retrieval success, defined as endovascular retrieval of complete filter. | At the time of retrieval procedure |
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Inclusion Criteria:
Exclusion Criteria:
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A patient dataset is deemed suitable for inclusion in the study if the patient has a procedure where a Celect Platinum Vena Cava Filter
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabina Andersen | Contact | +45 29 73 41 34 | sabina.hjorth@cookmedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States | |
Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request immediately after approval or clearance of the product and ending 5 years after approval or clearance. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
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| Hospital Universitari de Bellvitage |
| Recruiting |
| Barcelona |
| 08907 |
| Spain |
| Hospital Reina Sofia de Cordoba | Recruiting | Córdoba | 14004 | Spain |
| Parc Tauli | Recruiting | Sabadell | 08208 | Spain |
| Leeds Teaching Hospital NHS Trust | Recruiting | Leeds | West Yorkshire | LS1 3EX | United Kingdom |
| Hull University Teaching Hospitals NHS Trust | Recruiting | Hull | HU3 2JZ | United Kingdom |
| Royal Liverpool Hospital | Recruiting | Liverpool | L7 8XP | United Kingdom |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D054556 | Venous Thromboembolism |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013923 | Thromboembolism |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
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