Estudio posterior al mercado del filtro de vena cava Celect Platinum y del conjunto de recuperación de tulipanes Gunther
Estudio posterior al mercado del filtro de vena cava Celect Platinum y del conjunto de recuperación de tulipanes Günther
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sabina Andersen
- Número de teléfono: +45 29 73 41 34
- Correo electrónico: sabina.hjorth@cookmedical.com
Ubicaciones de estudio
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Barcelona, España, 08907
- Reclutamiento
- Hospital Universitari de Bellvitage
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Córdoba, España, 14004
- Reclutamiento
- Hospital Reina Sofia de Cordoba
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Sabadell, España, 08208
- Reclutamiento
- Parc Tauli
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California
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Los Angeles, California, Estados Unidos, 90048
- Reclutamiento
- Cedars-Sinai Medical Center
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Hull, Reino Unido, HU3 2JZ
- Reclutamiento
- Hull University Teaching Hospitals NHS Trust
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Liverpool, Reino Unido, L7 8XP
- Reclutamiento
- Royal Liverpool Hospital
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West Yorkshire
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Leeds, West Yorkshire, Reino Unido, LS1 3EX
- Reclutamiento
- Leeds Teaching Hospital NHS Trust
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
A patient dataset is deemed suitable for inclusion in the study if the patient has a procedure where a Celect Platinum Vena Cava Filter
Descripción
Inclusion Criteria:
- A patient dataset is deemed suitable for inclusion if the patient has a procedure where a Celect Platinum Vena Cava Filter is placed
- Subject has not previously participated in the Cook MDR-2126 study.
Exclusion Criteria:
- Patients will be excluded from enrollment if the patient or his/her legally authorized representative objects to collection and processing of his/her data or is not willing to sign the Informed Consent.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Patients indicated for the placement of a Celect Platinum Vena Cava Filter
Patients indicated for the placement of a Celect Platinum Vena Cava Filter |
Inferior vena cava filter |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Filter-related primary endpoint (safety)
Periodo de tiempo: Index procedure through 12-months post procedure
|
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
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Filter-related primary endpoint (performance)
Periodo de tiempo: 12-months post procedure
|
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
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Filter Retrieval-related primary endpoint
Periodo de tiempo: Through 30-days post procedure
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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
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Filter Retrieval-related primary endpoint
Periodo de tiempo: At the time of retrieval procedure
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Technical retrieval success, defined as endovascular retrieval of complete filter. |
At the time of retrieval procedure
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MDR-2126
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .