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

NCT ID NCT05409989

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

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.

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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

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