Plataforma de Registro de Vigilancia Postcomercialización (PSR) de Productos Neurovasculares

ReclutandoClinicalTrials.gov

ID: NCT02988128Tipo: OBSERVATIONALInicio: 1 de dic de 2016Fin estimado: 1 de ago de 2032

Resumen

Registro de vigilancia postcomercialización.

Descripción detallada

Registro observacional, prospectivo, multicéntrico y de un solo brazo para brindar evaluación continua e informes periódicos sobre la seguridad y eficacia de los productos comercializados de Medtronic Neurovascular utilizados en el tratamiento de aneurismas intracraneales y accidente cerebrovascular isquémico agudo. MDT16056 y MDT17077 se llevan a cabo bajo el Registro de Vigilancia de Productos (NCT01524276).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

For MDT16056 and MDT17077
Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements
Patient has, or is intended to receive or be treated with, an eligible Medtronic product
Patient is consented within the enrollment window of the therapy received, as applicable
Patient is at least 18 years of age at time of enrollment.
Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
Patient is treated or intended to be treated with an eligible Medtronic Neurovascular product.
Patient is an adult per local law at time of consent. Medtronic Business Restricted This document is electronically controlled CONFIDENTIAL 056-F275 Rev F Clinical Investigation Plan Template

Criterios de exclusión

Patient who is, or is expected to be inaccessible for follow-up
Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.
For MDT24028 and MDT22032:
Patient who may be unable to complete the study follow-up
Patient with any contraindications per the applicable Instructions for Use document
Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study
Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results.
Additional criteria may be required, refer to cohort-specific Addendum, as applicable, for further guidance.

Intervenciones

device

Treatment for intracranial aneurysms

Embolization of aneurysms

device

Treatment for Acute Ischemic Stroke

Revascularization of an intracranial blood vessel

Ubicaciones

ENERI

Buenos Aires, Argentina

COMPLETED

Patrocinadores

PrincipalMedtronic Neurovascular Clinical Affairs

ColaboradorMedtronic Cardiac Rhythm and Heart Failure

Contactos

Wouter Fabry

CONTACT

wouter.fabry@medtronic.com +32496165078

Beatrice Carlotta Sicurella

CONTACT

beatrice.carlotta.sicurella@medtronic.com +390224137264

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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