Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New Stent-Like device aims to seal brain aneurysms without surgery

NCT ID NCT05409989

Disease control Sponsor: Microvention-Terumo, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a device called FRED X, a small mesh tube placed inside an artery to block blood flow to a brain aneurysm. The goal is to see if it works as well as the earlier FRED device in preventing strokes and sealing the aneurysm. About 154 participants with a single aneurysm in the internal carotid artery are being followed for 12 months. The study is already done enrolling and is now in the follow-up phase.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FRED X device (a stent-like implant placed in the artery to block blood flow to the aneurysm)
What this could lead to
If successful, this study could confirm that the FRED X device is a safe and effective option for treating brain aneurysms, offering a less invasive alternative to open surgery.
What could go wrong
This is a post-approval study, not a new breakthrough. The device is already approved, so the main risk is that it may not perform as well as the earlier version. Complications like stroke or incomplete aneurysm closure are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 154 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Subjects for this study must meet ALL the following criteria: 1. Subject has single target aneurysm in the internal carotid artery from petrous segment to the terminus of the internal carotid artery. 2. The parent artery diameter must be 2.0 - 5.0 mm distal and/or proximal to the target intracranial aneurysm. 3. Negative pregnancy test (serum or urine) in a female subject who has had menses in the last 18 months. 4. 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. 5. The subject or his/her authorized representative must sign the IRB-approved written informed consent form prior to the start of any study procedures. 6. The subject has a modified Rankin Scale (mRS) ≤ 2. 7. The subject has a wide-necked ( ≥4mm or dome-to-neck ratio \<2) saccular or fusiform aneurysm. Exclusion Criteria: Subjects shall be excluded from the study if ANY of the following conditions exist: 1. Subject who suffers from a subarachnoid hemorrhage in the last 60 days. 2. Subject who suffers from intracranial hemorrhage in the last 30 days. 3. Subject who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region. 4. Subject with symptomatic extracranial or intracranial stenosis of the parent artery (\>50%) proximal to the target aneurysm. 5. 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. 6. Subject with history of major bleeding disorder (based on coagulation profile and platelet count) and/or subject presents with signs of active bleeding. 7. Subject with known hypersensitivity to any component of the treatment device that cannot be medically controlled. 8. Subject with documented contrast allergy, or other condition that prohibits imaging. 9. Evidence of active bacterial infection at the time of treatment. 10. 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%. 11. Subject with a pre-existing stent in place at the target aneurysm. 12. Subject who is unable to complete the required follow-ups. 13. Subject who is pregnant, breastfeeding, or of childbearing potential and unwilling to prevent pregnancy during their participation in the study. 14. Subject has a serious or life-threatening comorbidity that could confound study results and/or prevent completion of 5-year followup. 15. Subject is enrolled in another device or drug study in which participation could confound study results. 16. Subject has absent femoral pulses or other condition preventing femoral access, or is planned to be treated using a radial access approach.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Intracranial aneurysm are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

brain aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intracranial aneurysm

Contacts and locations

Locations

  • Albany Medical Center

    Albany, New York, 12208, United States

  • Baptist Healthcare System

    Louisville, Kentucky, 40207, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Massachusetts General Brigham Incorporated

    Boston, Massachusetts, 02114, United States

  • Memorial Healthcare Systems

    Hollywood, Florida, 33021, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Mount Sinai

    New York, New York, 10029, United States

  • Northwell Health

    Manhasset, New York, 11030, United States

  • Norton Healthcare

    Louisville, Kentucky, 40241, United States

  • Ochsner Health

    New Orleans, Louisiana, 70121, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Orlando Health

    Orlando, Florida, 32806, United States

  • ProMedica Toledo Hospital

    Toledo, Ohio, 43606, United States

  • Queen's Medical Center

    Honolulu, Hawaii, 96813, United States

  • Stony Brook University

    Stony Brook, New York, 11794, United States

  • The Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • UMass Memorial Health

    Worcester, Massachusetts, 01655, United States

  • University at Buffalo

    Buffalo, New York, 14203, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Kansas

    Kansas City, Kansas, 66160, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.