Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms

MicroVention

Status: Completed

Conditions: Intracranial Aneurysms

Treatments: Device: Flow Re-Direction Endoluminal Device (FRED)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01801007

G120111 (Other Identifier)

CL12001

Details and patient eligibility

About

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.

Enrollment: 145 patients

Sex: All

Ages: 22 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant whose age ≥ 22 and ≤75 years
• Participant has single target aneurysm located in the internal carotid artery
• Participant sign and date an IRB/EC approved informed consent prior initiation of any study procedures

Exclusion criteria

• Participant who suffers from an intracranial hemorrhage in the last 30 days
• Participant who suffers from a subarachnoid hemorrhage in the last 60 days
• Participant with symptomatic extracranial mass or currently undergoing radiation therapy for tumor of the head and neck region
• Participant who is pregnant or breastfeeding
• Participant has an arteriovenous malformation (AVM) in the area of the target aneurysm

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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145 participants in 1 patient group

Flow Re-Direction Endoluminal Device

Other group

Treatment:

Device: Flow Re-Direction Endoluminal Device (FRED)