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New coil treatment aims to seal brain aneurysms

NCT ID NCT05563051

Disease control Sponsor: Kaneka Medical America LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a procedure that uses tiny coils to block blood flow in brain aneurysms (bulging blood vessels). The goal is to seal the aneurysm and prevent rupture. About 164 people with aneurysms 4-14mm in size are being followed for one year after treatment.

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 164 people

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

Started

Dec 2022

Expected to finish

Dec 2025

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: * Target aneurysm of 4mm - 14mm in size * Ruptured or unruptured * Suitable for embolization with coils * May be treated with or without assist devices Exclusion Criteria: * Unstable neurological deficit in unruptured cases (condition worsening within last 90 days) * Pre-planned staged procedure of target aneurysm * mRS score 3 or more * Hunt Hess Score more than 3 for subjects with ruptured aneurysm * Evidence of active infection (e.g.,fever, temperature \>38 degrees C and/or WBC \>15,000)

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Conditions

The condition(s) this trial relates to.

Aneurysm brain aneurysm

As listed by the trial registrant

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

Aneurysm cerebral

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • McLaren Health Care

    Grand Blanc, Michigan, 48439, United States

  • Northwell Health Lenox Hill Hospital

    New York, New York, 10075, United States

  • SSM Health St. Anthony's Hospital

    Oklahoma City, Oklahoma, 73102, United States

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