CLARYS: CLinical Assessment of WEB® Device in Ruptured aneurYSms (NCT02687607) | Clinical Trial Compass
CompletedNot Applicable
CLARYS: CLinical Assessment of WEB® Device in Ruptured aneurYSms
France60 participantsStarted 2016-01
Plain-language summary
An observational non-randomized, multi-center, prospective assessment of the clinical utility of the WEB Aneurysm Embolization System in subjects with ruptured intracranial aneurysms deemed appropriate for endovascular treatment. The population being treated in this Registry is a subset of the CE marked indication.
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
. The decision to use a WEB device to treat the patient has been made before and independently of the decision to include the patient in this Registry
. Subject must be ≥ 18 years and \< 80 years of age
. Subject must have a single intracranial aneurysm ruptured within 30 days requiring treatment according to a multidisciplinary decision Definition: For the purposes of this study a ruptured IA patient is defined as a patient with computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP) evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 30 days.
. If the subject has one or more additional aneurysm, the additional aneurysm must not require treatment in emergency or within 30 days of the index procedure
. Subject with Hunt \& Hess Score of I, II or III
. Conventional or Flat-panel CT is performed within 6hrs prior to femoral puncture (or just before WEB placement if any clinical worsening is noted before the treatment) to assess absence of re-bleeding prior the treatment
. Aneurysm to be treated must have the following characteristics i. Morphology - saccular ii. Location
. Subject must be considered by the physician to be available for subsequent visits
Exclusion criteria
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.