Clinical Trial: Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Pivotal Study of the MicroVention Flow Re-Direction Endoluminal Device (FRED) Stent System in the Treatment of Intracranial Aneurysms

Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of the MicroVention Flow Redirection Intraluminal Device (FRED) system when used in the treatment of wide-necked intracranial aneurysms.

Detailed Summary:
Sponsor: Microvention-Terumo, Inc.

Current Primary Outcome: Proportion of subjects who experience neurological death or major ipsilateral stroke measured by the modified Rankin Scale(mRS)and the National Institute of Health Stroke Scale (NIHSS) [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence of FRED system and procedure related serious adverse events [ Time Frame: 12 months ]

Original Secondary Outcome: Same as current

Information By: Microvention-Terumo, Inc.

Dates:
Date Received: February 26, 2013
Date Started: July 2013
Date Completion: August 2017
Last Updated: April 11, 2017
Last Verified: September 2016