Clinical trial NCT01801007: Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms
Official title: Pivotal Study of the MicroVention Flow Re-Direction Endoluminal Device (FRED) Stent System in the Treatment of Intracranial Aneurysms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Aneurysms
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-28
Enrollment: 145
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: FRED
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Complete Occlusion of the Target Aneurysm and ≤50% Stenosis of the Parent Artery and an Alternative Treatment of the Target Intracranial Aneurysm (IA) Had Not Been Performed Within 12 Months
timeFrame: 12 months
measure: Percentage of Participants Who Experience Neurological Death or Major Ipsilateral Stroke Measured by the Modified Rankin Scale (mRS) and the National Institute of Health Stroke Scale (NIHSS)
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of Participants With Complete Occlusion of the Target Aneurysm on 12-month Angiography (Raymond-Roy 1)
timeFrame: 12 months
measure: Percentage of Participants With ≥ 50% In-Stent Stenosis (ISS) at the Target Intracranial Aneurysm (IA) at 12 Months as Assessed by Angiography at the Independent Core Laboratory
timeFrame: 12 months
measure: Percentage of Participants in Whom an Unplanned Alternative Treatment of the Target IA Had Not Been Performed Within 12 Months
timeFrame: 12 months
measure: Percentage of Participants With Clinically Acceptable (90-100%) Occlusion of the Target Aneurysm, ≤ 50% Stenosis of the Parent Artery at the Target IA, and an Unplanned Alternative Treatment of the Target IA Had Not Been Performed
timeFrame: 12 months
measure: Percentage of Participants With Unsuccessful Delivery of the FRED
timeFrame: Index Procedure
measure: Percentage of Participants That Had Procedure Related Serious Adverse Events With the FRED System
timeFrame: 12 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Englewood
country: United States
facility: Swedish Medical Center / RIA
state: Colorado
city: Jacksonville
country: United States
facility: Lyerly Neurosurgery
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Louisville
country: United States
facility: Norton Neuroscience Institute
state: Kentucky
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Trenton
country: United States
facility: Capital Health Hospital
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai Health System
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
city: Houston
country: United States
facility: Baylor Saint Luke Medical Center
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Kobe
country: Japan
facility: Institute of Biomedical Research and Innovation
Study officials:
affiliation: Johns Hopkins University
name: Cameron McDougall, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McDougall CG, Diaz O, Boulos A, Siddiqui AH, Caplan J, Fifi JT, Turk AS, Kayan Y, Jabbour P, Kim LJ, Hetts SW, Cooke DL, Dowd CF. Safety and efficacy results of the Flow Redirection Endoluminal Device (FRED) stent system in the treatment of intracranial aneurysms: US pivotal trial. J Neurointerv Surg. 2022 Jun;14(6):577-584. doi: 10.1136/neurintsurg-2021-017469. Epub 2021 Jul 19.