Intracranial AneurysmNCT05409989
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
A study testing FRED™ X™ in people with Intracranial Aneurysm, run by Microvention-Terumo, Inc. at 23 sites in United States.
Trial summary
The objective of this study is to generate contemporaneous clinical data to facilitate a reasonable comparison of the performance of the FRED™ X™ device with the performance of the FRED™ device. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- FRED™ X™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 23 sitesUnited States
- Study dates
- 20 Sep 2022to May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Subjects for this study must meet ALL the following criteria:
- Subject has single target aneurysm in the internal carotid artery from petrous segment to the terminus of the internal carotid artery.
- The parent artery diameter must be 2.0 - 5.0 mm distal and/or proximal to the target intracranial aneurysm.
- Negative pregnancy test (serum or urine) in a female subject who has had menses in the last 18 months.
- Subject commits to return to the investigational site for the 30- day, 6-month, 12-month, 2-year, 3-year, and 5-year follow-up evaluations.
- The subject or his/her authorized representative must sign the IRB-approved written informed consent form prior to the start of any study procedures.
- The subject has a modified Rankin Scale (mRS) ≤ 2.
- The subject has a wide-necked ( ≥4mm or dome-to-neck ratio <2) saccular or fusiform aneurysm.
Who cannot join
- Subjects shall be excluded from the study if ANY of the following conditions exist:
- Subject who suffers from a subarachnoid hemorrhage in the last 60 days.
- Subject who suffers from intracranial hemorrhage in the last 30 days.
- Subject who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region.
- Subject with symptomatic extracranial or intracranial stenosis of the parent artery (>50%) proximal to the target aneurysm.
- Subject with an irreversible bleeding disorder, a platelet count < 100 x 103 cells/mm3 or known platelet dysfunction or a contraindication to or inability to tolerate anticoagulants/antiplatelet agents or thrombolytic drugs.
Show all 17Show fewer
- Subject with history of major bleeding disorder (based on coagulation profile and platelet count) and/or subject presents with signs of active bleeding.
- Subject with known hypersensitivity to any component of the treatment device that cannot be medically controlled.
- Subject with documented contrast allergy, or other condition that prohibits imaging.
- Evidence of active bacterial infection at the time of treatment.
- Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction less than 30%.
- Subject with a pre-existing stent in place at the target aneurysm.
- Subject who is unable to complete the required follow-ups.
- Subject who is pregnant, breastfeeding, or of childbearing potential and unwilling to prevent pregnancy during their participation in the study.
- Subject has a serious or life-threatening comorbidity that could confound study results and/or prevent completion of 5-year followup.
- Subject is enrolled in another device or drug study in which participation could confound study results.
- Subject has absent femoral pulses or other condition preventing femoral access, or is planned to be treated using a radial access approach.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Albany Medical Center
Albany, New York, 12208
The Johns Hopkins University
Baltimore, Maryland, 21287
Massachusetts General Brigham Incorporated
Boston, Massachusetts, 02114
University at Buffalo
Buffalo, New York, 14203
Ohio State University
Columbus, Ohio, 43210
Memorial Healthcare Systems
Hollywood, Florida, 33021
Queen's Medical Center
Honolulu, Hawaii, 96813
Houston Methodist Hospital
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
University of Kansas
Kansas City, Kansas, 66160
Baptist Healthcare System
Louisville, Kentucky, 40207
Norton Healthcare
Louisville, Kentucky, 40241
Northwell Health
Manhasset, New York, 11030
Ochsner Health
New Orleans, Louisiana, 70121
Mount Sinai
New York, New York, 10029
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Orlando Health
Orlando, Florida, 32806
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Stony Brook University
Stony Brook, New York, 11794
Montefiore Medical Center
The Bronx, New York, 10467
ProMedica Toledo Hospital
Toledo, Ohio, 43606
UMass Memorial Health
Worcester, Massachusetts, 01655
About this study
The objective of this study is to generate contemporaneous clinical data to facilitate a reasonable comparison of the performance of the FRED™ X™ device with the performance of the FRED™ device. The data generated from this study will be compared to the safety and effectiveness of the FRED™ device by meeting the same performance goals (PGs) established for the FRED™ pivotal study.
- Conditions
- Intracranial Aneurysm
- Being tested
- FRED™ X™
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRED™ X™Device
Also called Flow Re-Direction Endoluminal Device X
The FRED™ X™ System is indicated for use in the internal carotid artery from the petrous segment to the terminus for the endovascular treatment.
| Study group | Role | What they receive |
|---|---|---|
| Flow Re-Direction Endoluminal Device X | Other | FRED™ X™ device Receives: Device: FRED™ X™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint Part 1: Proportion of subjects that experience either Death or major stroke within 30 days post-procedure.
Major stroke is defined as a new neurological event that persists for >24 hours and results in a ≥4-point increase in the NIHSS score compared to baseline or compared to any subsequent lower score.
Measured: 30-days
Primary Safety Endpoint Part 2: Proportion of subjects that experience neurological death or major ipsilateral stroke within 12 months post-procedure.
A major ipsilateral stroke is defined as that occurring within the vascular distribution of the stented artery. Neurological death is defined as a death which has been adjudicated by an independent clinical events committee to have directly resulted from a neurologic cause.
Measured: 12 months
Primary Effectiveness Endpoint: The percent of subjects with (1) complete (100%) occlusion of the target aneurysm and ≤50% stenosis of the parent artery at the target IA, and (2) in whom an alternative treatment of the target IA had not been performed.
(1) Complete (100%) occlusion of the target aneurysm is assessed utilizing the Raymond-Roy Scale (Raymond Roy Class 1) and ≤50% stenosis of the parent artery at the target IA), and in whom an alternative treatment of the target IA had not been performed. The study will utilize independent Core Laboratory to adjudicate all angiographic outcomes, including aneurysm occlusion status and parent artery stenosis. (2) Alternative treatment 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start20 Sep 2022
- Primary completionApr 2026 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Microvention-Terumo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409989
- Sponsor's protocol ID
- CL11023
- Status last verified
- Mar 2026
- First submitted
- 4 Jun 2022
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
- ClinicalTrials.gov ID
- NCT05409989
- Acronym / sponsor ID
- CL11023
- Conditions
- Intracranial Aneurysm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to generate contemporaneous clinical data to facilitate a reasonable comparison of the performance of the FRED™ X™ device with the performance of the FRED™ device. The data generated from this study will be compared to the safety and effectiveness of the FRED™ device by meeting the same performance goals (PGs) established for the FRED™ pivotal study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flow Re-Direction Endoluminal Device X | Other | Device: FRED™ X™FRED™ X™ device |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject has single target aneurysm in the internal carotid artery from petrous segment to the terminus of the internal carotid artery.
- The parent artery diameter must be 2.0 - 5.0 mm distal and/or proximal to the target intracranial aneurysm.
- Negative pregnancy test (serum or urine) in a female subject who has had menses in the last 18 months.
- Subject commits to return to the investigational site for the 30- day, 6-month, 12-month, 2-year, 3-year, and 5-year follow-up evaluations.
- The subject or his/her authorized representative must sign the IRB-approved written informed consent form prior to the start of any study procedures.
Key exclusion criteria (17 listed)
- Subject who suffers from a subarachnoid hemorrhage in the last 60 days.
- Subject who suffers from intracranial hemorrhage in the last 30 days.
- Subject who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region.
- Subject with symptomatic extracranial or intracranial stenosis of the parent artery (>50%) proximal to the target aneurysm.
- Subject with an irreversible bleeding disorder, a platelet count < 100 x 103 cells/mm3 or known platelet dysfunction or a contraindication to or inability to tolerate anticoagulants/antiplatelet agents or thrombolytic drugs.
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 |
|---|---|---|
| FRED™ X™Also: Flow Re-Direction Endoluminal Device XThe FRED™ X™ System is indicated for use in the internal carotid artery from the petrous segment to the terminus for the endovascular treatment. | Device | Flow Re-Direction Endoluminal Device X |
Primary outcome
Primary Safety Endpoint Part 1: Proportion of subjects that experience either Death or major stroke within 30 days post-procedure.
Time frame: 30-days
Major stroke is defined as a new neurological event that persists for >24 hours and results in a ≥4-point increase in the NIHSS score compared to baseline or compared to any subsequent lower score.
Primary Safety Endpoint Part 2: Proportion of subjects that experience neurological death or major ipsilateral stroke within 12 months post-procedure.
Time frame: 12 months
A major ipsilateral stroke is defined as that occurring within the vascular distribution of the stented artery. Neurological death is defined as a death which has been adjudicated by an independent clinical events committee to have directly resulted from a neurologic cause.
Primary Effectiveness Endpoint: The percent of subjects with (1) complete (100%) occlusion of the target aneurysm and ≤50% stenosis of the parent artery at the target IA, and (2) in whom an alternative treatment of the target IA had not been performed.
Time frame: 12 months
(1) Complete (100%) occlusion of the target aneurysm is assessed utilizing the Raymond-Roy Scale (Raymond Roy Class 1) and ≤50% stenosis of the parent artery at the target IA), and in whom an alternative treatment of the target IA had not been performed. The study will utilize independent Core Laboratory to adjudicate all angiographic outcomes, including aneurysm occlusion status and parent artery stenosis. (2) Alternative treatment 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FRED™ X™ in people with Intracranial Aneurysm, run by Microvention-Terumo, Inc. at 23 sites in United States.
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 8 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Primary Safety Endpoint Part 1: Proportion of subjects that experience either Death or major stroke within 30 days post-procedure. (time frame: 30-days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2026.