NCT02687607

CLARYS: CLinical Assessment of WEB® Device in Ruptured aneurYSms

CLinical Assessment of WEB® Device in Ruptured aneurYSms

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Microvention-Terumo, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

An observational non-randomized, multi-center, prospective assessment of the clinical utility of the WEB Aneurysm Embolization System in subjects with ruptured intracranial aneurysms deemed appropriate for endovascular treatment. The population being treated in this Registry is a subset of the CE marked indication.

Detailed description

All eligible subjects presenting to the participating Registry Center will be considered for entry into the Registry. Up to 70 evaluable subjects meeting the Registry entry criteria will be enrolled. An intermediary analysis will be performed when the first forty (40) subjects reaching the planned one month follow-up. subjects will be followed per Institution's standard of care.

Conditions

• Brain Aneurysm

Interventions

Type	Name	Description
DEVICE	WEB Aneurysm Embolization System

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-10-10
• Completion: 2018-12-04
• First posted: 2016-02-22
• Last updated: 2023-01-26

Locations

1 site across 1 country: France