Clinical Trial: CLARYS: CLinical Assessment of WEB® Device in Ruptured aneurYSms

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: CLinical Assessment of WEB® Device in Ruptured aneurYSms

Brief 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.

Detailed Summary:

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.


Sponsor: Sequent Medical, Inc

Current Primary Outcome: 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.

Definitions:

  1. 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
  2. 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.



Original Primary Outcome: Same as current

Current Secondary Outcome: Aneurysm occlusion [ Time Frame: 12 months ]

Angiographic (conventional or CT-Angio or MR-Angio) occlusion at 12month based on WEB occlusion scale (WOS)


Original Secondary Outcome: Same as current

Information By: Sequent Medical, Inc

Dates:
Date Received: February 16, 2016
Date Started: January 2016
Date Completion: June 2018
Last Updated: October 12, 2016
Last Verified: October 2016