To assess safety and efficacy of pCONus for the treatment of wide neck bifurcation aneurysms.
Who can participate
Age range
18 Years – 80 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
. Aneurysm status:
. Age ≥18 and ≤ 80 years.
. The patient or legal representative provides written informed consent.
. The patient shows general compliance to follow the medical regimen and to attend follow-up examinations.
. The target aneurysm is located at one of the following cerebral vessel bifurcations: ICA terminus, AcomA, MCA or BA.
. Bifurcation wide neck aneurysm.
. The dome height should allow for safe deployment of the device crown. The fundus of the aneurysm should offer enough space for the crown of the pCONus to deploy.
Exclusion criteria
. Vessel tortuosity precluding safe access and device deployment.
. Stenosis within the vascular access or target vessel ≥ 50 %.
. The target aneurysm has been previously treated with a stent or an intraaneurysmal implant beside coils.
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
Effectiveness Aneurysm occlusion (complete or neck remnant)
Timeframe: Change from post-procedure to 3-6 and to 7-12 months
2
Safety Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm
. The treatment plan for the target aneurysm includes the use of additional intra- and/or extraaneurysmal temporary or permanent implants other than coils.
. More than one intracerebral aneurysm requires the treatment within the following 6 months.
. Imaging evidence of an arteriovenous cerebrovascular malformation or a dural fistula.
. Any physical, medical or psychiatric condition of the patient interfering with the adherence of the requirements and follow-up regimen of the study.
. Any neurological disorder with progressive neurological symptoms, except attributable to a compressive effect of the target aneurysm.