A Medical Device to Treat Wide-Neck Brain Aneurysms (NCT05550571) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Medical Device to Treat Wide-Neck Brain Aneurysms
United States, Bulgaria45 participantsStarted 2022-12-17
Plain-language summary
The study aims to evaluate the safety and probable benefit of a medical device to treat wide-neck ruptured brain aneurysms.
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
. Subject is ≥18 years old
. Subject who presents with an angiographically confirmed, wide neck intracranial saccular, acutely ruptured aneurysm. Wide neck is defined as 4-7mm.
. Aneurysm dome ≥5 mm.
. Subject is neurologically stable with a Hunt \& Hess score of I, II, or III.
. In the opinion of the treating physician, placement of the Nautilus is technically feasible and clinically reasonable.
. The subject or authorized representative is able to provide informed consent and has signed the IRB-approved informed consent form.
. Subject must be able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule.
Exclusion criteria
. Subject with any neurological deficit occurred within the last 180 days; defined as previous non-aneurysmal subarachnoid hemorrhage or any other non-aneurysmal intracranial hemorrhage, stroke, transient ischemic attacks (TIA), concussion, head trauma, cranial surgery, radiation therapy to the head.
. Premorbid mRS score ≥3.
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
The proportion of subjects experiencing death or stroke
. Subject has another aneurysm which, in the Investigator's opinion, will require treatment within the follow-up period (1 year).
. Women of child-bearing potential age (18-55) who cannot provide a negative pregnancy test.
. Subject with other serious comorbidities that carry a high risk of neurologic events such as:
. Severe or unstable conditions or diseases (e.g., non-significant neurological deficit, cancer, hematologic or coronary disease) or chronic conditions that in the opinion of the investigator may increase the risk associated with study participation for study device administration or may interfere with the interpretation of study results.
. Extreme vessel stenosis or tortuosity or other vascular anomalies that would prevent delivery of the device to the target.
. Comorbidities that may preclude obtaining follow-up DSA.