The purpose of this study is to assess safety and effectiveness of the p64 Flow Modulation Device.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18
. Patient harbours either one saccular or one dissecting or one blisterlike or one fusiform intracerebral aneurysm or one intracerebral segmental disease, in the anterior circulation for which the indication for p64 treatment is given
. Patient or legal representative provides written informed consent verifying that he/she consents to the use of his/her data (according to the data protection laws)
Exclusion criteria
. Aneurysms of the posterior circulation
. Imaging evidence of bifurcation aneurysms
. Imaging evidence of dissections
. Imaging evidence of fistulae
. Imaging evidence of arteriovenous malformations
. Patient is harbouring another aneurysm that has to be treated within six months after first procedure
. Known allergy to study medication, e.g. ASA, Clopidogrel, Heparin or contrast media
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the rate of complete occlusion
Timeframe: immediately after treatment, an expected average of 1 hour; to 12 months
2
Change of frequency of major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm
Timeframe: immediately after treatment, an expected average of 1 hour; to 12 months