WEB PAS
Recruiting
99 years and younger
All
Phase
N/A
48 participants needed
1 Location
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.
- Key effectiveness outcome is the proportion of subjects with adequate aneurysm occlusion at one year after treatment.
- 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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