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

Intracranial Aneurysms Clinical Trial

— FRED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801007
• Other study ID #: CL12001
• Secondary ID: G120111
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: January 2018

Study information

• Verified date: February 2021
• Source: Microvention-Terumo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Intracranial Aneurysms

Intervention

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

Locations

Country	Name	City	State
Japan	Institute of Biomedical Research and Innovation	Kobe
United States	Albany Medical Center	Albany	New York
United States	Emory University	Atlanta	Georgia
United States	The Johns Hopkins Hospital	Baltimore	Maryland
United States	Tufts Medical Center	Boston	Massachusetts
United States	University at Buffalo	Buffalo	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Swedish Medical Center / RIA	Englewood	Colorado
United States	Baylor Saint Luke Medical Center	Houston	Texas
United States	The Methodist Hospital	Houston	Texas
United States	Lyerly Neurosurgery	Jacksonville	Florida
United States	Norton Neuroscience Institute	Louisville	Kentucky
United States	North Shore University Hospital	Manhasset	New York
United States	Methodist University Hospital	Memphis	Tennessee
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Mount Sinai Health System	New York	New York
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University	Saint Louis	Missouri
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Capital Health Hospital	Trenton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Microvention-Terumo, Inc.

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The primary effectiveness endpoint has three components: 1) complete occlusion of the target aneurysm assessed by a core laboratory utilizing the Raymond-Roy Scale 2) = 50% stenosis of the parent artery at the target (IA) using the Warfarin-Aspirin Symptomatic Intracranial Disease(WASID) criterion which is defined as greater than 50% luminal loss, 3) alternative treatment of the target IA is defined as re-treatment of the target aneurysm with an alternative treatment modality including open repair, endovascular placement of an additional stent or treatment of In-stent Stenosis observed. The Raymond-Roy Occlusion Classification has 3 responses, where Grade I is complete occlusion, no flow of contrast seen in the sac, Grade II is partial occlusion, some flow in the neck or sac, and Grade III is incomplete occlusion, apparent flow into the sac. Grade 1 indicates the best outcome.	12 months
Primary	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)	A major stroke is defined as a new neurological event that persists for > 24 hours and results in a = 4 points increase in the NIHSS score compared to baseline or compared to any subsequent lower score. A major ipsilateral stroke is defined as that occurring within the vascular distribution of the stented artery. Neurologic death is defined as a death which has been adjudicated by the independent clinical events committee to have directly resulted from a neurologic cause.The NIHSS score ranges from 0 (no stroke symptoms) to 42 (severe stroke). mRS is 6 point assessment scale used to assess disability in patients who have suffered a stroke and is compared over time to check for recovery and degree of continued disability. The mRS score ranges from 0 (no disability) to 6 (death).	12 months
Secondary	Percentage of Participants With Complete Occlusion of the Target Aneurysm on 12-month Angiography (Raymond-Roy 1)	Complete occlusion of the target aneurysm assessed by a core laboratory. The Raymond-Roy class is an angiographic classification scheme for grading the occlusion (closure) of endovascularly treated intracranial aneurysms: class I: complete obliteration, class II: residual neck, class III: residual aneurysm.	12 months
Secondary	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	Stenosis of the parent artery at the target IA using the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) criterion which is defined as greater than 50% luminal loss	12 months
Secondary	Percentage of Participants in Whom an Unplanned Alternative Treatment of the Target IA Had Not Been Performed Within 12 Months	Re-treatment of the target aneurysm with an alternative treatment modality including open repair, endovascular placement of an additional stent or treatment of In-stent Stenosis observed	12 months
Secondary	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	This endpoint has three components: 1) clinically acceptable occlusion of the target aneurysm assessed by a core laboratory as percent occlusion (90%-100%) 2) = 50% stenosis of the parent artery at the target IA using the WASID criterion which is defined as greater than 50% luminal loss, 3) alternative treatment of the target IA is defined as re-treatment of the target aneurysm with an alternative treatment modality including open repair, endovascular placement of an additional stent or treatment of In-stent Stenosis observed. The Raymond-Roy scale has 3 responses, where Grade I is complete occlusion, no flow of contrast seen in the sac, Grade II is partial occlusion, some flow in the neck or sac, and Grade III is incomplete occlusion, apparent flow into the sac.	12 months
Secondary	Percentage of Participants With Unsuccessful Delivery of the FRED	Inability to deliver a FRED device to the target location	Index Procedure
Secondary	Percentage of Participants That Had Procedure Related Serious Adverse Events With the FRED System	A serious adverse event is any medical experience regardless of its relationship to the study treatment that occurs during participant enrollment in this trial that results in any of the following: (1) inpatient hospitalization or prolongation of a hospitalization; (b) persistent or significant disability or incapacity; (c) death of the study participant, or (d) necessitates an intervention to prevent a permanent impairment of a body function or permanent damage to a body structure. Procedure related events were associated with the index procedure, antiplatelet therapy, or follow up angiography.	12 months