The purpose of this study is to evaluate the safety and effectiveness of the HARBOR Occlusion Device for treating brain aneurysms. The HARBOR Device is investigational (experimental), meaning the Regulatory Authorities have not approved it for commercial use. The data collected in this research study will be used to analyze whether the HARBOR Device is safe and effective in treating brain aneurysms.
Nuvascular is sponsoring a prospective, single-center, single arm clinical trial to assess the safety and effectiveness of the HARBOR Occlusion Device for the treatment of unruptured intracranial aneurysms.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Intervention with HARBOR Occlusion Device
University Hospital St. Ivan Rilski
Sofia, Bulgaria
Participants meeting the primary safety and effectiveness endpoints
The study's primary effectiveness endpoint is the proportion of subjects with complete aneurysm occlusion without retreatment, recurrent subarachnoid hemorrhage, without significant parent artery stenosis (\>50% stenosis) at one year after treatment. A subject will be considered an effectiveness success upon meeting all the above criteria. The study's primary safety endpoint is the proportion of subjects with death of any nonaccidental cause or any major stroke (defined as an ischemic or hemorrhagic stroke resulting in an increase of 4 points or more on the National Institutes of Health Stroke Scale) 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. A subject will be considered a safety failure upon meeting any of the above criteria. All safety events will be adjudicated by an independent clinical events committee.
Time frame: 10-14 months
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