New coil aims to seal brain aneurysms safely
NCT ID NCT07464847
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Semmes Murphey Clinic
Memphis, Tennessee, 38120, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a smart app make brain aneurysm Follow-Up better?