Prospective, Multicenter, Single Arm Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device

CompletadoClinicalTrials.gov

ID: NCT02600364Tipo: OBSERVATIONALInicio: 1 de dic de 2015Fin estimado: 1 de jun de 2020

Neurología

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to assess safety and effectiveness of the p64 Flow Modulation Device.

Descripción detallada

Title: Diversion-p64. Device: p64 Flow Modulation Device. Study design: Prospective, multicenter, single arm Post Market Clinical Follow-Up Study. Purpose: To assess safety and effectiveness of p64. Study duration: 48 months. Sample Size: 400 patients. Number of sites: \> 20. Follow-up intervals: Two independent follow-ups (after 3-6 and 7-12 months) according to site specific standard.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Age ≥ 18
Patient harbours either one saccular or one dissecting or one blisterlike or one fusiform intracerebral aneurysm or one intracerebral segmental disease, in the anterior circulation for which the indication for p64 treatment is given
Patient or legal representative provides written informed consent verifying that he/she consents to the use of his/her data (according to the data protection laws)

Criterios de exclusión

Aneurysms of the posterior circulation
Imaging evidence of bifurcation aneurysms
Imaging evidence of dissections
Imaging evidence of fistulae
Imaging evidence of arteriovenous malformations
Patient is harbouring another aneurysm that has to be treated within six months after first procedure
Known allergy to study medication, e.g. ASA, Clopidogrel, Heparin or contrast media
Confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication)
Current involvement in another study or trial
Parent vessel treated with other Flow Diverters than p64 during intervention and re-treatment

Ubicaciones

Clínica La Sagrada Familia

Buenos Aires, Argentina

Patrocinadores

PrincipalPhenox GmbH

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