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New coil aims to seal brain aneurysms safely

NCT ID NCT07464847

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 will test a special coil called the Penumbra PC400 in 100 adults aged 18 to 80 who have a medium or large brain aneurysm (5 mm or bigger). The coil is placed inside the aneurysm to block blood flow and prevent rupture or rebleeding. Researchers will track how well the aneurysm stays closed over 18 months and monitor for serious problems like stroke or death.

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.

Participants

About 100 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

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.

Who is studied

All eligible subjects presenting to a participating study site will be considered for enrollment. Up to 100 patients ≥ 18 and ≤ 80 years presenting with ruptured or unruptured saccular aneurysms who meet all eligibility criteria will be enrolled. Enrolled subjects must be treated with Penumbra PC400 coils used in any combination comprising a minimum of 80% total coil length used.

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: * Subject is ≥ 18 and ≤ 80 years of age. * Subject has a previously untreated, ruptured or unruptured, saccular intracranial aneurysm 5mm or more in diameter for which the clinical decision to treat with Penumbra PC400 embolization coils has been made independent of the decision to enroll the subject in the study described in this protocol. * The decision to undergo the coiling procedure is made independently of and prior to participation in the research. * Subject has a baseline Hunt and Hess Score of I, II, or III. * Subject must be considered by the treating physician to be available for and able to complete all follow-up visits. * Subject has not been previously entered into this study. Exclusion Criteria: * Subject is \< 18 or \> 80 years of age. * Subject has a baseline Hunt and Hess score of IV or V. * Target aneurysm is dissecting, fusiform, blister-like, mycotic, tumoral, or AVM related. * Target aneurysm maximum diameter is \<5mm * Target aneurysm was previously treated via clipping or coiling. * Target aneurysm is deemed by the treating physician to be unsuitable for coiling or unlikely to be successfully treated by endovascular techniques. * Target aneurysm has not been confidently determined by the treating physician to be the source of SAH. * Planned use of a flow diverter (Surpass, Pipeline, Silk, FRED, p64, etc.) or intrasaccular device (WEB, Artis, Medina, etc.) as a component of the target aneurysm treatment plan. * Intended use of a coil-assist stent as a component of the target aneurysm treatment plan, unless stent is used for bailout purposes. * Subject has a known, untreatable hypersensitivity to contrast dye, iodine, hydrogel, or any other component of the treatment device. * Subject has a contraindication to heparin or aspirin. * Subject has vascular anatomy/tortuosity preventing access to the target aneurysm. * Subject is unable to undergo DSA or DSA is determined unsuitable or outside standard of care by the treating physician. * Subject has a serious or life-threatening comorbidity that could confound study results. * Subject is at high risk of noncompliance due to a history of substance abuse, psychosocial issues, etc. * Subject is unable to complete scheduled follow-up assessments due to comorbidities, geographical limitations, or a life expectancy of less than 18 months. * Subject is pregnant, breastfeeding, or plans to become pregnant prior to completion of follow-up. * Subject is enrolled in another device or drug study in which participation could confound study results.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Semmes Murphey Clinic

    Memphis, Tennessee, 38120, United States

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