Not yet taking people in United StatesNo phase

Following people treated with PC400 coils for brain aneurysms

Looks at PC400 coil safety and aneurysm closure in adults with brain aneurysms.

Key facts

Who runs it: Semmes-Murphey Foundation
Where: Memphis, United StatesSee the site
Trial code: NCT07464847
Registry title: PC400 Coils for Treatment of Intracranial Aneurysms
Status: Not yet recruiting
People taking part: 100 people, planned
Started: May 2026
Expected to end: Dec 2029
Type of study: Observational
Record updated: 11 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a saccular (berry-shaped) brain aneurysm 5mm or more, burst or not, whose doctor has already decided to treat it with Penumbra PC400 coils.

Age: 18 to 80 years
Sex: All sexes
Disease stage: Saccular brain aneurysm 5mm or more across, ruptured or unruptured. Hunt and Hess score I, II or III (a scale of how severe a brain bleed is).
Earlier treatment: The aneurysm must not have been treated before, by clipping or coiling.

Main reasons for not taking part

Hunt and Hess score IV or V
Aneurysm smaller than 5mm, or of a dissecting, fusiform, blister-like, mycotic, tumour or AVM-related type
Planned use of a flow diverter, an intrasaccular device, or a coil-assist stent (except as a bailout)
Allergy to contrast dye, iodine, hydrogel or device parts, or cannot take heparin or aspirin
Pregnant, breastfeeding, or planning pregnancy before follow-up ends

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

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 take part

Target aneurysm was previously treated via clipping or coiling
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
Subject has a known, untreatable hypersensitivity to contrast dye, iodine, hydrogel, or any other component of the treatment device
Subject is at high risk of noncompliance due to a history of substance abuse, psychosocial issues, etc
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 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 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 unable to complete scheduled follow-up assessments due to comorbidities, geographical limitations, or a life expectancy of less than 18 months

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 80 years old?

Where in United States

Semmes Murphey ClinicMemphis, United StatesContact: Olivia HouseNot yet recruiting

About the trial

What the trial wants to find out

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 full original descriptionShow less

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.