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New coil aims to plug brain aneurysms more safely and cheaply

NCT ID NCT05636124

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 new coil device (Kaneka i-ED) in 50 people with wide-necked brain aneurysms. The coil is placed inside the aneurysm to block blood flow and prevent rupture. Researchers will check how well it works, how safe it is, and whether it saves money compared to standard treatments over 18 months.

What this could mean

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

Active substance
Kaneka i-ED coil (a medical device used to block blood flow into brain aneurysms)
What this could lead to
If successful, this coil could offer a safer, more cost-effective way to treat wide-necked brain aneurysms, reducing the need for repeat procedures.
What could go wrong
This is a small, early-stage study with only 50 participants and no control group. The device may not work better than existing options, and there are risks of serious complications like bleeding or stroke.

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

50 people

The number who actually took part.

Started

Jun 2023

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Patient presenting with ruptured or unruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neuroendovascular treating team * Wide neck side wall or bifurcation intracranial aneurysms (neck \> or = to 4 mm or dome-to-neck ratio \< 2) within the anterior or posterior circulation * The neurointerventionist feels that the aneurysm can be safely treated using endovascular techniques (direct or assisted coiling) * Patients are 18-80 years of age (inclusive) * Patient must be Hunt and Hess grade 0 to 3 * Patient has given fully informed consent to endovascular coiling procedure. If the patient cannot consent for themselves, appropriate written consent has been sought from their next of kin or appropriate power of attorney. * Aneurysm 6-14 mm in diameter * Patient is willing and able to return for clinical evaluation and follow-up imaging evaluation (angiography) at 3-6 months and 12-18 months after endovascular treatment * The patient has not been previously enrolled in this trial or another related ongoing trial * The aneurysm has not been previously treated by coiling or clipping Exclusion criteria: * Patient has more than one aneurysm requiring treatment in the current treatment session, and only one of those to be treated aneurysms fits the Kaneka inclusion criteria (i.e., - if either (1) a patient has multiple aneurysms, but only one will be treated at enrollment; or (2) if two or more aneurysms are treated during the current treatment session and BOTH are able to be enrolled, then they remain eligible for the trial). Non-treated additional aneurysms may be treated at a later date with any coil type that the operator chooses). * Target aneurysm has had previous coil treatment or has been surgically clipped * Hunt and Hess score is 4 or 5 after subarachnoid hemorrhage * Inability to obtain informed consent * Medical or surgical comorbidity such that the patient's life expectancy is less than 2 years

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Baptist Health Jacksonville

    Jacksonville, Florida, 32207, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Prisma Health

    Greenville, South Carolina, 29605, United States

  • Sutter Health

    Danville, California, 94526, United States

  • University of South Florida

    Tampa, Florida, 33606, United States

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