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 range18 Years – 80 Years
SexALL
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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