CLARYS: CLinical Assessment of WEB® Device in Ruptured aneurYSms (CLARYS)
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|ClinicalTrials.gov Identifier: NCT02687607|
Recruitment Status : Recruiting
First Posted : February 22, 2016
Last Update Posted : August 31, 2017
|Condition or disease||Intervention/treatment|
|Brain Aneurysm||Device: WEB Aneurysm Embolization System|
All eligible subjects presenting to the participating Registry Center will be considered for entry into the Registry. Up to 70 evaluable subjects meeting the Registry entry criteria will be enrolled.
An intermediary analysis will be performed when the first forty (40) subjects reaching the planned one month follow-up.
subjects will be followed per Institution's standard of care.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||50 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||CLinical Assessment of WEB® Device in Ruptured aneurYSms|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||June 2018|
WEB Aneurysm Embolization System
Subjects aged ≥ 18 years, but ≤ 80 years requiring treatment for single ruptured intracranial aneurysms.
Device: WEB Aneurysm Embolization System
- Re-Bleed rate after treatment [ Time Frame: 1 month ]
Re-bleeding rate after treatment of the target aneurysm with WEB, during the period extending from post-procedure up to 1 month.
- Re-bleeding from target aneurysm is defined as patent evidence of hemorrhage on CT or MRI AND hemorrhage is depicted in the same territory as the initial bleeding AND hemorrhage has increased in size compare to initial pre-operative CT
- Screening for re-bleeding: During hospital stay of the patient and up to 1-month, any worsening of the clinical status should lead to perform a non-enhanced CT or MRI.
Or, as per-center standard care, non-enhanced CT or MRI might be performed systematically during hospital course.
- Aneurysm occlusion [ Time Frame: 12 months ]Angiographic (conventional or CT-Angio or MR-Angio) occlusion at 12month based on WEB occlusion scale (WOS)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687607
|Contact: Patricia Boyer||33 email@example.com|
|Contact: Amy Walters||(949) firstname.lastname@example.org|
|Service de Neuroradiologie||Recruiting|
|Bicetre, Le Kremlin-Bicetre, France, 94270|
|Principal Investigator: Laurent Spelle, MD, PhD|
|Principal Investigator:||Laurent Spelle, MD, PhD||CHU Bicetre|