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

NCT01801007 | Completed Results DMC

• 2 other identifiers: CL12001G120111
• Study Type: interventional
• Target: 145
• Locations: 2 countries
• Sites: 24

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.

Conditions

Intracranial Aneurysms

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Percentage of Participants With Complete Occlusion of the Target Aneurysm on 12-month Angiography (Raymond-Roy 1)

  12 months

• 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

  12 months

• Percentage of Participants in Whom an Unplanned Alternative Treatment of the Target IA Had Not Been Performed Within 12 Months

  12 months

• 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

  12 months

• Percentage of Participants With Unsuccessful Delivery of the FRED

  Index Procedure

Study Arms (1)

Flow Re-Direction Endoluminal Device

OTHER

Device: Flow Re-Direction Endoluminal Device (FRED)

Interventions

Flow Re-Direction Endoluminal Device (FRED) DEVICE

Flow Re-Direction Endoluminal Device

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Microvention-Terumo, Inc.: lead

Study Sites (24)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Swedish Medical Center / RIA

Englewood, Colorado, 80113, United States

Location

Lyerly Neurosurgery

Jacksonville, Florida, 32207, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Norton Neuroscience Institute

Louisville, Kentucky, 40202, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic

Rochester, Minnesota, 55903, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Capital Health Hospital

Trenton, New Jersey, 08638, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

University at Buffalo

Buffalo, New York, 14203, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Mount Sinai Health System

New York, New York, 10019, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Methodist University Hospital

Memphis, Tennessee, 38104, United States

Location

Baylor Saint Luke Medical Center

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Institute of Biomedical Research and Innovation

Kobe, 650-0047, Japan

Location

Related Publications (1)

• 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.

  PMID: 34282038 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Senior Manager, Clinical Quality Compliance and Clinical Operations
• Organization: MicroVention, Inc., A TERUMO Group Company

jennifer.jelf@microvention.com

714-247-8000

Study Officials

• Cameron McDougall, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: FRED

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: February 28, 2013
• Study Start: July 1, 2013
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: March 8, 2021
• Results First Posted: October 9, 2020

Record last verified: 2021-02

Locations

US (23); JP (1)