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Safety and Efficacy Analysis of FRED™/FRED™Jr Embolic Device in Aneurysm Treatment

Intracranial Aneurysm Clinical Trial

Official title:
Safety and Efficacy Analysis of FRED™/FRED™Jr Embolic Device in Aneurysm Treatment, a UK, Multi-center, Single Arm, Prospective Observational Study

Clinical Trial Summary

A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms

Clinical Trial Description

This is a multi-center observational study. Treatment and follow-up visits will be done as per standard of care. The purpose of this study is to demonstrate that use of the FRED/FRED Jr Embolic device in intracranial aneurysm treatment is safe and effective when assessed at 1, 6 and 12 month post procedure. 100 patients will be enrolled over an 18-month recruitment period. All patients will be followed for 12 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03423290
Study type Observational
Source Microvention-Terumo, Inc.
Contact
Status Completed
Phase
Start date November 23, 2017
Completion date January 26, 2022
View Details
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