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Brain aneurysm coils put to the test in largest Real-World study

NCT ID NCT03642639

Disease control Sponsor: Cerenovus, Part of DePuy Synthes Products, 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 10, 2026 · Updated 3 times

Summary

This study tracked 723 people with brain aneurysms treated using MICRUSFRAME and GALAXY coils, sometimes with a PulseRider device. The goal was to see how well the coils blocked the aneurysm and kept it closed after 12 months. Researchers collected data from real hospital settings to understand the devices' everyday performance.

What this could mean

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

Active substance
MICRUSFRAME and GALAXY coils (medical devices used to block blood flow to an aneurysm)
What this could lead to
If successful, this could confirm that these coils are a safe and effective option for treating brain aneurysms in everyday medical practice.
What could go wrong
This is an observational registry, not a controlled trial, so results may not prove the coils are better than other treatments. Some aneurysms may still reopen over time.

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

723 people

The number who actually took part.

Started

Aug 2018

Finished

Jun 2025

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

21 to 80 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: 1. Patient is between 21 and 80 years of age 2. Patient has an intracranial saccular aneurysm, ruptured or unruptured, suitable for embolization with coils 3. Patient is able and willing to comply with protocol and follow-up requirements Exclusion Criteria: 1. Pre-planned staged procedure on unruptured aneurysm 2. More than one aneurysm requiring treatment during the course of study 3. Fusiform aneurysm

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Conditions

The condition(s) this trial relates to.

Aneurysm brain aneurysm intracranial berry aneurysm

As listed by the trial registrant

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

Aneurysms

Contacts and locations

Locations

  • Aichi Medical University Hospital

    Aichi, Japan

  • Algemeen Ziekenhuis Groeninge

    Kortrijk, Belgium

  • Baptist Medical Center

    Jacksonville, Florida, 32207, United States

  • Centre Hospitalier Regional Universitaire de Tours

    Tours, France

  • Centre Hospitalier Universitaire d'Amiens Picardie

    Amiens, France

  • Centre Hospitalier Universitaire de Bordeaux

    Bordeaux, France

  • Centro Hospitalar de Vila Nova de Gaia

    Porto, Portugal

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Galilee Hospital Naharyia

    Nahariya, Israel

  • Geisinger Clinic

    Danville, Pennsylvania, 17822, United States

  • Greenville Health System

    Greenville, South Carolina, 61103, United States

  • Hopital Roger Salengro-Centre Hospitalier Universitaire de Lille

    Lille, France

  • Hopitaux Universitaires de Geneve

    Geneva, Switzerland

  • Hospital Universitari i Politecnic La Fe

    Valencia, Spain

  • Javon Bea Hospital

    Rockford, Illinois, 61103, United States

  • Kohnan Hospital

    Sendai, Japan

  • Maine Medical Center

    Scarborough, Maine, 04074, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Meihokai Yokohama Shin-Toshi Brain Orthopedic Hospital

    Yokohama, Japan

  • Memorial Health University

    Savannah, Georgia, 31405, United States

  • Mercy Health St. Vincent Medical Center

    Toledo, Ohio, 43604, United States

  • Mercy San Juan Medical Center

    Carmichael, California, 95608, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • National Hospital Organization Osaka National Hospital

    Osaka, Japan

  • Norton Healthcare

    Louisville, Kentucky, 40241, United States

  • Okayama University Hospital

    Okayama, Japan

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Ospedale Cannizzaro

    Sicily, Italy

  • Ospedale Niguarda Ca' Granda

    Milan, Italy

  • Policlinico Tor Vergata

    Roma, Italy

  • Praticien Hospitalier Université de Lorraine

    Nancy, France

  • Rush University

    Chicago, Illinois, 60612, United States

  • St. Louis University

    St Louis, Missouri, 63110, United States

  • Stony Brook University

    Stony Brook, New York, 11794, United States

  • Tennessee Interventional and Imaging Associates

    Chattanooga, Tennessee, 37403, United States

  • Texas Stroke Institute

    Plano, Texas, 75075, United States

  • Tominaga Hospital

    Osaka, Japan

  • Universitatsklinikum Schleswig Holstein

    Lübeck, Germany

  • University Hospital Zurich

    Zurich, Switzerland

  • University of Arizona

    Tucson, Arizona, 85724, United States

  • University of Buffalo

    Buffalo, New York, 14075, United States

  • University of California Irvine

    Orange, California, 92868, United States

  • University of Florida

    Gainesville, Florida, 32608, United States

  • University of Illinois

    Chicago, Illinois, 60612, United States

  • University of Massachusetts

    Worcester, Massachusetts, 01655, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Tennessee

    Knoxville, Tennessee, 37920, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

  • Westchester Medical Center

    Valhalla, New York, 10595, United States

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