Intracranial AneurysmsPC400NCT07464847
PC400 Coils for Treatment of Intracranial Aneurysms
An observational study of Intracranial Aneurysms and Saccular Aneurysm, run by Semmes-Murphey Foundation at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysms, Saccular Aneurysm
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2026to Dec 2029
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Semmes Murphey Clinic
Memphis, Tennessee, 38120
Olivia House, 901-522-7785, ohouse@semmes-murphey.com
Courtney Berryman, 901-260-6111, cberryman@semmes-murphey.com
About this study
Official title: Penumbra PC400 Coils for Treatment of Medium and Large Sized (5mm or More) Intracranial Aneurysms: A Prospective Multicenter Study
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.
Read the detailed description
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.
- Conditions
- Intracranial Aneurysms, Saccular Aneurysm
- Keywords
- Intracranial aneurysm, Coiling
- Medical subject headings
- Intracranial Aneurysm, Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure- or disease-related death or major stroke
Procedure- or disease-related death or major stroke within 30 days of treatment
Measured: 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
Measured: 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).
Measured: 18 months post-procedure
Secondary outcomes (6)
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.
Measured: 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.
Measured: 18 months post-procedure
Packing density
Packing density as measured by volumetric filling of the aneurysm immediately post-procedure
Measured: Immediately post-procedure
Retreatment rate due to recurrence
Retreatment rate due to recurrence at 18 months
Measured: 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)
Measured: 18 months post-procedure
Occlusion stability at 18 months
Occlusion stability at 18 ± 6 months (same, better, or worse compared to posttreatment results)
Measured: 18 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study startMay 2026 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Semmes-Murphey Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nitin Goyal, MD, Principal investigator, Semmes Murphey Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464847
- Sponsor's protocol ID
- PC400 GEN II
- Acronym
- PC400
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD to be shared will include all IPD that underlie results of the publication.
Publications
Mascitelli JR, Polykarpou MF, Patel AA, Kamath AA, Moyle H, Patel AB. Initial experience with Penumbra Coil 400 versus standard coils in embolization of cerebral aneurysms: a retrospective review. J Neurointerv Surg. 2013 Nov;5(6):573-6. doi: 10.1136/neurintsurg-2012-010483. Epub 2012 Sep 19.
PubMed 22993243Berge J, Gariel F, Marnat G, Dousset V. PC400 volumetric coils minimize radiation, reduce procedure time and optimize packing density during endovascular treatment in medium sized cerebral aneurysms. J Neuroradiol. 2016 Feb;43(1):37-42. doi: 10.1016/j.neurad.2015.10.002. Epub 2015 Dec 11.
PubMed 26687722Kulcsar Z, Wanke I, Rufenacht D, Wetzel SG, Goricke S, Kolia K, Quarfordt S, Calvert J, Hawk H, Baxter B. Safety and effectiveness of large volume coils in the treatment of small aneurysms. J Neurointerv Surg. 2016 Dec;8(12):1260-1263. doi: 10.1136/neurintsurg-2015-012100. Epub 2016 Jan 20.
PubMed 26790826
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penumbra PC400 Coils for Treatment of Medium and Large Sized (5mm or More) Intracranial Aneurysms: A Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT07464847
- Acronym / sponsor ID
- PC400 / PC400 GEN II
- Conditions
- Intracranial Aneurysms, Saccular Aneurysm
- Keywords
- Intracranial aneurysm, Coiling
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Semmes-Murphey FoundationUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 18 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Procedure- or disease-related death or major stroke
Time frame: 30 days post-procedure
Procedure- or disease-related death or major stroke within 30 days of treatment
Stroke, neurological death, or rebleeding from target aneurysm
Time frame: 18 months post procedure
Major ipsilateral stroke, neurological death or rebleeding from the target aneurysm during the 18-month follow-up period
Adequate angiographic occlusion
Time frame: 18 months post-procedure
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).
6 secondary outcomes
30-day Modified Rankin Scale (mRS)
Time frame: 30 days post procedure
18-month Modified Rankin Scale (mRS)
Time frame: 18 months post-procedure
Packing density
Time frame: Immediately post-procedure
Retreatment rate due to recurrence
Time frame: 18 months post-procedure
Angiographic occlusion at 18 months
Time frame: 18 months post-procedure
Occlusion stability at 18 months
Time frame: 18 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Background: PubMed 22993243Mascitelli JR, Polykarpou MF, Patel AA, Kamath AA, Moyle H, Patel AB. Initial experience with Penumbra Coil 400 versus standard coils in embolization of cerebral aneurysms: a retrospective review. J Neurointerv Surg. 2013 Nov;5(6):573-6. doi: 10.1136/neurintsurg-2012-010483. Epub 2012 Sep 19.
- Background: PubMed 26687722Berge J, Gariel F, Marnat G, Dousset V. PC400 volumetric coils minimize radiation, reduce procedure time and optimize packing density during endovascular treatment in medium sized cerebral aneurysms. J Neuroradiol. 2016 Feb;43(1):37-42. doi: 10.1016/j.neurad.2015.10.002. Epub 2015 Dec 11.
- Background: PubMed 26790826Kulcsar Z, Wanke I, Rufenacht D, Wetzel SG, Goricke S, Kolia K, Quarfordt S, Calvert J, Hawk H, Baxter B. Safety and effectiveness of large volume coils in the treatment of small aneurysms. J Neurointerv Surg. 2016 Dec;8(12):1260-1263. doi: 10.1136/neurintsurg-2015-012100. Epub 2016 Jan 20.
- Individual participant dataSharing planned: Yes. IPD to be shared will include all IPD that underlie results of the publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nitin Goyal, MD principal investigator
Semmes Murphey Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysms and Saccular Aneurysm, run by Semmes-Murphey Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nitin Goyal (901-522-7700, ngoyal@semmes-murphey.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure- or disease-related death or major stroke (time frame: 30 days post-procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07464847, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.