WEB PAS

Brief description of study

The primary objective of this post-market surveillance study is to evaluate the long-term safety and effectiveness of the WEB® Device within currently approved indications for use.
  1. Key effectiveness outcome is the proportion of subjects with adequate aneurysm occlusion at one year after treatment.
  2. Key safety outcome includes the proportion of subjects with death of any nonaccidental cause or any major stroke* within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment. Major stroke is defined as an ischemic or hemorrhagic stroke resulting in an increase of 4 points or more on the National Institutes of Health Stroke Scale. - Rebleed rate - ruptured cohort. - Aneurysm occlusion rate as the proportion of subjects with adequate aneurysm occlusion using the WOS occlusion scale. - Antiplatelet regimen physician discretion unruptured cohort - The long-term stability defined as complete occlusion outcomes with the WEB device, without retreatment or recurrent subarachnoid hemorrhage. Imaging and clinical follow-up examination to be performed at 1, 3, and 5-year post procedure. - IA occlusion stability (WOS A, WOS B). -Subjects experiencing death by ipsilateral neurological cause, any ipsilateral stroke event (disabling and non-disabling), or additional neurological deficits1 within 1 year post-procedure, and new and ongoing adverse events at subsequent study visits. 1 Additional neurological deficits to be recorded: Ischemic Stroke ICH SAH Vasospasm Protocol number CL11010-001 Revision A: 29Mar2021 Confidential Page 10 of 52 Arterial Thrombosis Perforation/Rupture of parent or branch artery Stenosis Parent or branch artery Hemoptysis Seizure Transient Ischemic Attack (TIA) *Disabling stroke is defined as an ischemic or hemorrhagic stroke resulting in an mRS of 3 or more.
-Neurological deficits using validated neurological assessments such as the modified Rankin Scale (mRS) and NIHSS scores - Quality of Life measure (patient reported) e.g. EQ-5D (unruptured cohort only).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Medical Research
  • Age: - 99 Years
  • Gender: All

TBD

Updated on 09 Mar 2024. Study ID: 852177

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