Intracranial AneurysmsFREDNCT01801007

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

A study testing Flow Re-Direction Endoluminal Device (FRED) in people with Intracranial Aneurysms, run by Microvention-Terumo, Inc. at 24 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 22 to 75 years
Conditions the study is for: Intracranial Aneurysms
What is being tested?: Flow Re-Direction Endoluminal Device (FRED)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 145 participants
Where: 24 sitesin 2 countries
Study dates: Jul 2013to Jan 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

24 sites in 2 countries.

Country

City, postcode or hospital

24 sites in 2 countries

United States23 sites

Albany Medical Center
Albany, New York, 12208
Emory University
Atlanta, Georgia, 30322
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Tufts Medical Center
Boston, Massachusetts, 02111
University at Buffalo
Buffalo, New York, 14203
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
Swedish Medical Center / RIA
Englewood, Colorado, 80113
Baylor Saint Luke Medical Center
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
Lyerly Neurosurgery
Jacksonville, Florida, 32207
Norton Neuroscience Institute
Louisville, Kentucky, 40202
North Shore University Hospital
Manhasset, New York, 11030
Methodist University Hospital
Memphis, Tennessee, 38104
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Mount Sinai Health System
New York, New York, 10019
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Mayo Clinic
Rochester, Minnesota, 55903
Washington University
St Louis, Missouri, 63110
Stony Brook University Medical Center
Stony Brook, New York, 11794
Capital Health Hospital
Trenton, New Jersey, 08638

Other trials in United States

Japan1 site

Institute of Biomedical Research and Innovation
Kobe, 650-0047

Other trials in Japan

About this study

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

Conditions: Intracranial Aneurysms
Being tested: Flow Re-Direction Endoluminal Device (FRED)
Medical subject headings: Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Flow Re-Direction Endoluminal Device (FRED)Device

Study groups in NCT01801007
Study group	Role	What they receive
Flow Re-Direction Endoluminal Device	Other	Not described Receives: Device: Flow Re-Direction Endoluminal Device (FRED)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 12 months

Secondary outcomes (6)

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.
Measured: 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
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
Measured: 12 months
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
Measured: 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
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.
Measured: 12 months
Percentage of Participants With Unsuccessful Delivery of the FRED
Inability to deliver a FRED device to the target location
Measured: Index Procedure
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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Jan 2018

First posted28 Feb 2013 (estimated)
Study startJul 2013
Primary completionJan 2018
Study completionJan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Intracranial AneurysmsStudies of the same condition, open and under way.
More trials run by Microvention-Terumo, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: FRED
Masking: None (open label)
Enrolment: 145 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01801007
Sponsor's protocol ID: CL12001
Other IDs: G120111
Acronym: FRED
Status last verified: Feb 2021
First submitted: 26 Feb 2013
Last updated: 8 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 34282038

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Intracranial Aneurysms trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pivotal Study of the MicroVention Flow Re-Direction Endoluminal Device (FRED) Stent System in the Treatment of Intracranial Aneurysms
ClinicalTrials.gov ID: NCT01801007
Acronym / sponsor ID: FRED / CL12001
Conditions: Intracranial Aneurysms
Study type: Interventional
Recruitment status: Completed
Enrolment: 145 participants (actual)
Lead sponsor: Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: Jan 2018 (actual)
Study completion: Jan 2018 (actual)
First posted: 28 Feb 2013 (estimated)
Results: Posted 9 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: FRED

Arm	Type	Receives
Flow Re-Direction Endoluminal Device	Other	Device: Flow Re-Direction Endoluminal Device (FRED)

Who may qualify

Ages: 22 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Flow Re-Direction Endoluminal Device (FRED)	Device	Flow Re-Direction Endoluminal Device

Primary outcome

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
Time frame: 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.
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)
Time frame: 12 months
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).

6 secondary outcomes

Percentage of Participants With Complete Occlusion of the Target Aneurysm on 12-month Angiography (Raymond-Roy 1)
Time frame: 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
Time frame: 12 months
Percentage of Participants in Whom an Unplanned Alternative Treatment of the Target IA Had Not Been Performed Within 12 Months
Time frame: 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
Time frame: 12 months
Percentage of Participants With Unsuccessful Delivery of the FRED
Time frame: Index Procedure
Percentage of Participants That Had Procedure Related Serious Adverse Events With the FRED System
Time frame: 12 months

Results and safety

Results posted to the registry on 9 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Flow Re-Direction Endoluminal Device	145	134

Primary outcome: 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

Time frame: 12 months. Number. Unit: percentage of participants

Measure	Flow Re-Direction Endoluminal Device n = 139
Value	57.0

Population analysed: Participants that had 12 month angiographic assessment of vessel stenosis

Primary outcome: 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)

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Flow Re-Direction Endoluminal Device n = 145
Value	9

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Flow Re-Direction Endoluminal Device	63 of 145 (43.4%)	61 of 145 (42.1%)	2 of 145

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34282038McDougall 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cameron McDougall, MD principal investigator

Johns Hopkins University

24 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Flow Re-Direction Endoluminal Device (FRED) in people with Intracranial Aneurysms, run by Microvention-Terumo, Inc. at 24 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01801007, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.