An observational study in Intracranial Aneurysms and Saccular Aneurysm, sponsored by Semmes-Murphey Foundation. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by Semmes-Murphey Foundation · Observational
The goal of this prospective, observational study is to evaluate the long-term occlusion rates and safety of the Penumbra PC400 coil in the treatment of ruptured and unruptured intracranial aneurysms in adult subjects ages 18-80.
Specifically, the study aims to analyze rate of death, stroke, neurological death, or rebleeding associated with the treatment of intracranial aneurysm with the PC400 coil.
Participants will undergo standard of care treatment and follow up for their aneurysm treatment, and participating sites will collect procedural and follow up data.
Endovascular treatment has become the primary approach for intracranial aneurysms, offering improved safety and reduced recanalization rates. Despite advancements in flow diversion and intrasaccular devices, coiling remains a cornerstone therapy. However, aneurysmal recurrence due to regrowth or coil compaction continues to be a significant concern, with recurrence observed in about 20% of cases, leading to potential rebleeding and treatment challenges.
The Penumbra PC400 coil (Penumbra Inc., Alameda, CA, USA) addresses these concerns by offering 400% more volume per unit length than traditional 0.010-inch coils. This design also reduces procedure and fluoroscopy times, improving overall efficiency. Several retrospective reports have highlighted its advantages in packing density, procedure time, and cost-effectiveness.1,2,3 However, there is a lack of high-level prospective data to support these findings.
The goal of the present study is to determine occlusion rates and safety when Penumbra PC400 coils are used in the treatment of ruptured or unruptured medium and large sized (5mm or more) intracranial aneurysms.
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.
The primary safety endpoint is procedure- or disease-related death or major stroke within 30 days of treatment or major ipsilateral stroke, neurological death or rebleeding from the target aneurysm during the 18-month follow-up period. The primary efficacy endpoint is Adequate angiographic occlusion at 18 ± 6 months without interim retreatment secondary to aneurysm recurrence or rebleed of the target aneurysm. This will be assessed by an imaging core lab using digital subtraction angiograms (DSA).
Secondary endpoints include Clinical outcome (mRS) at 30 days, clinical outcome (mRS) at 18 months, packing density as measured by volumetric filling of the aneurysm immediately post-procedure, mean number of coils, procedural duration (in minutes), retreatment rate due to recurrence at 18 months, adequate angiographic occlusion at 18 without rebleed of the target aneurysm, occlusion stability at 18 months, peri-/post-procedural adverse events related to the device and/or the procedure.
Data will be shared with the coordinating center, Semmes Murphey Foundation, via a secure electronic database, REDCap. Access to the REDCap database will only be granted to IRB approved research personnel from participating sites. Subjects will be given a subject ID in the database. Throughout the data collection period, investigators may maintain a linking key that links the subject to their ID. This linking key will only be accessible to the investigator and site personnel. Once data collection has been completed, the linking key will be erased so that there will be no way to re-link subjects with their research data. Research data from each site will only be accessible to the approved research personnel at that site; authorized research personnel from the coordinating center will only have access to the coded data in the REDCap database for each site for study monitoring purposes. No patient contact will occur outside of standard of care procedures. Participating sites will execute a Data Use Agreement (DUA) with the coordinating center.
418 studies on the registry are indexed under Intracranial Aneurysm; 119 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 191 observational studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Semmes-Murphey Foundation is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure- or disease-related death or major stroke
Procedure- or disease-related death or major stroke within 30 days of treatment
Time frame: 30 days post-procedure
Stroke, neurological death, or rebleeding from target aneurysm
Major ipsilateral stroke, neurological death or rebleeding from the target aneurysm during the 18-month follow-up period
Time frame: 18 months post procedure
Adequate angiographic occlusion
Adequate angiographic occlusion at 18 ± 6 months without interim retreatment secondary to aneurysm recurrence or rebleed of the target aneurysm. This will be assessed by the core lab using digital subtraction angiograms (DSA).
Time frame: 18 months post-procedure
30-day Modified Rankin Scale (mRS)
Clinical outcome (mRS) at 30 days (20 - 60 days). Scores range from 0-6, zero = no symptoms, six = dead.
Time frame: 30 days post procedure
18-month Modified Rankin Scale (mRS)
Clinical outcome (mRS) at 18 ± 6 months. Scores range from 0-6, zero = no symptoms, six = dead.
Time frame: 18 months post-procedure
Packing density
Packing density as measured by volumetric filling of the aneurysm immediately post-procedure
Time frame: Immediately post-procedure
Retreatment rate due to recurrence
Retreatment rate due to recurrence at 18 months
Time frame: 18 months post-procedure
Angiographic occlusion at 18 months
Adequate angiographic occlusion at 18 ± 6 months without rebleed of the target aneurysm (regardless of retreatment status)
Time frame: 18 months post-procedure
Occlusion stability at 18 months
Occlusion stability at 18 ± 6 months (same, better, or worse compared to posttreatment results)
Time frame: 18 months post-procedure
Procedural duration
Procedural duration (minutes)
Time frame: Procedural
Number of coils
Mean number of coils
Time frame: Procedural
Adverse events related to the coils/coiling procedure
Peri-/post-procedural adverse events related to the device and/or the procedure
Time frame: Up to 18 months following the procedure
Plan to share: Yes — IPD to be shared will include all IPD that underlie results of the publication.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: The IPD will be available following study completion estimated to be in 2029 with no set end date.
Access criteria: A designated biostatistician will access study IPD. Access will be established through secure electronic transfer. Following publication, results and supporting information will be established on the ClinicalTrials.gov website.
Start is estimated for May 2026; primary completion for Nov 2029, 42 months later.
Of 67 non-industry observational studies under Intracranial Aneurysm, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 145. This study's planned 42 months is below that.
Counting every sponsor, half of 104 studies reached it within 46 months; a quarter within 36 and three quarters within 145.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Semmes-Murphey Foundation