Cure My Disease

Don't miss your cure!

 Log in / Sign up

New coil device aims to seal brain aneurysms without surgery

NCT ID NCT04057352

Disease control Sponsor: Stryker Neurovascular 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 new device called the Citadel Embolization Device, a coil used to block blood flow in brain aneurysms. It involves 150 adults aged 18-80 with unruptured or recently ruptured wide-neck aneurysms. The goal is to see if the device safely and effectively seals the aneurysm, preventing future bleeding.

What this could mean

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

Active substance
Citadel Embolization Device (a coil used to block blood flow in brain aneurysms)
What this could lead to
If successful, this device could offer a safer, less invasive way to treat wide-neck brain aneurysms, potentially reducing the need for surgery.
What could go wrong
This is a single-arm study with no comparison group, so results may be less definitive. Risks include stroke or incomplete aneurysm closure.

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 150 people

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

Started

Jul 2019

Expected to finish

Nov 2026

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

18 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. Age is ≥18 and ≤80 years 2. Has a single, unruptured or ruptured target intracranial aneurysm that is suitable for endovascular treatment. Definition: For the purposes of this study, a ruptured intracranial aneurysm is defined as one with CT/MRI/LP evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 60 days. 3. Aneurysm morphology is saccular 4. Aneurysm size is between 6-12 mm 5. Has a wide-neck, saccular aneurysm, either bifurcation or sidewall, with a dome to neck ratio \<2 or neck ≥4 mm 6. If the target intracranial aneurysm is classified as ruptured, patient must be neurologically stable with a Hunt \& Hess Score of 1 or 2. 7. Must be willing to comply with protocol required procedures and follow up 8. Subject or LAR must be willing to sign and date an IRB approved written informed consent prior to initiation of any screening or study procedures Exclusion Criteria: 1. Target aneurysm has been previously treated 2. Target aneurysm is in any extradural location, including the extradural cavernous segment 3. Has vessel characteristics, tortuosity or morphology or unfavorable aneurysm morphology (e.g., determined from baseline or preprocedure imaging, or which may be evidenced by excessive resistance felt during the procedure) that would preclude safe endovascular access to the target aneurysm necessary for treatment with the study device 4. Has significant intracranial atherosclerotic disease or stenosis determined from baseline or pre-procedure imaging 5. If the target intracranial aneurysm is classified as ruptured, patient is neurologically unstable or has a Hunt \& Hess Score of ≥ 3 6. Has a history of intracranial vasospasm not responsive to medical therapy 7. Has undergone coiling or stenting of a non-target intracranial aneurysm within 30 days prior to study treatment or has a non-target intracranial aneurysm that is expected to be treated within 12 months following the treatment of the target aneurysm 8. Treatment with flow diverting stent implant is anticipated 9. A planned, staged procedure is anticipated 10. Has Moya-Moya disease, arteriovenous malformation(s), arteriovenous fistula(e), intracranial tumor(s), intracranial hematoma(s), any other intracranial vascular malformation, or any previous major intracranial surgery 11. Has had a recent (within 90 days) ischemic stroke, TIA, or intracranial hemorrhage 12. Has a baseline mRS score ≥2 13. Has a known coagulopathy or is on chronic anticoagulant therapy 14. Is pregnant or intends to become pregnant during the study or is breastfeeding 15. Is concurrently involved in another study that could affect outcomes of IA treatment 16. Has evidence of active cancer, terminal illness, high risk of embolic stroke, unstable atrial fibrillation, significant co-morbidities, major surgery ≤ 30 days pre-procedure, psychiatric disorders, substance abuse, or a life expectancy of less than 5 years 17. Has a contraindication to angiography, radiographic contrast agents, or any medications that are typically used during the procedure, and any other contraindications listed in the Investigational DFU 18. Has a confirmed allergy to platinum, tungsten, nickel (e.g. nitinol), or other elements used in the manufacturing of the investigational device

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Unruptured wide-neck aneurysms are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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.

Unruptured wide-neck aneurysms

Contacts and locations

Locations

  • Baptist Health

    Jacksonville, Florida, 32207, United States

  • Baptist Health

    Lexington, Kentucky, 40503, United States

  • California Pacific Medical Center

    San Francisco, California, 94114, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Indiana Methodist

    Indianapolis, Indiana, 46202, United States

  • John Muir Health

    Walnut Creek, California, 94598, United States

  • Kansas University Medical Center

    Kansas City, Kansas, 66160, United States

  • McLaren Health Center

    Flint, Michigan, 48532, United States

  • Montefiore Medical Center

    New York, New York, 10467, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • RIA Neurovascular

    Englewood, Colorado, 80113, United States

  • Spectrum Health

    Grand Rapids, Michigan, 49503, United States

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • UCSF Medical Center

    San Francisco, California, 94143, United States

  • UMass Memorial Health

    Worcester, Massachusetts, 01605, United States

  • University of Florida

    Gainesville, Florida, 32608, United States

  • University of Kentucky

    Lexington, Kentucky, 40506, United States

  • University of Miami/Jackson Memorial

    Miami, Florida, 33136, United States

  • University of Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19104, United States

  • University of Washington

    Seattle, Washington, 98104, United States

  • Washington University

    St Louis, Missouri, 63110, United States

  • Weill Cornell

    New York, New York, 10021, United States

  • West Virginia University Hospital

    Morgantown, West Virginia, 26506, United States