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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: The study population includes adults with intracranial aneurysms | Experimental | Intervention: Aneurysm treatment with the HARBOR Occlusion Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aneurysm occlusion with an intrasaccular device | Device | Intervention with HARBOR Occlusion Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10-14 months |
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Inclusion Criteria:
Patient must be 18-79 years of age at the time of screening.
Patient must have a single unruptured IA requiring treatment. If the subject has an additional IA requiring treatment, the additional IA must not require treatment within 60 days of the index procedure.
The index IA to be treated must have the following characteristics:
Patient has an IA that is appropriate for treatment with HARBOR Occlusion Device without the use of additional implanted devices
Patient must be able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule. Patient must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures.
Patient must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital St. Ivan Rilski | Sofia | Bulgaria |
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