A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of Flowise Cerebral Flow Diverter (Flowise)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and short-term effectiveness of implantation of 'Flowise Cerebral Flow Diverter' for the treatment of unruptured wide-necked cerebral aneurysm in the internal carotid artery.

Detailed Description
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Flowise is indicated for use in patients with unruptured wide-necked aneurysm in the internal carotid artery. Consecutive subject data should be collected at discharge, 1, 3, and 6 month post Flowise implantation.

Official Title
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A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of 'Flowise Cerebral Flow Diverter' for the Treatment of Unruptured Wide-necked Cerebral Aneurysm in the Internal Carotid Artery

Conditions
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Intracranial Aneurysm

Intervention / Treatment
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* Device: Flowise Cerebral Flow Diverter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Functional neurological state ≤2 mRS Unruptured wide-neck aneurysm in the internal carotid artery has a size >8mm, a neck ≥4mm, or dome/neck ratio <2 Parent artery with diameter ≥3.25mm and ≤4.5mm Patient willing to provide written informed consent and comply with follow-up requirements Exclusion Criteria: Intracranial hemorrhage within 30 days Untreated ruptured intracranial aneurysm ≥1 intracranial aneurysm except the target one requires treatment within 6 months Immunosuppressive disease Active infectious disease (e.g. endocarditis, meningitis) Platelet count < 100 x 103 cells/mm3 Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flowise Cerebral Flow Diverter<br>Flowise Cerebral Flow Diverter (TaeWoong Medical Co., Ltd. Korea) | Device: Flowise Cerebral Flow Diverter<br>* Flowise Cerebral Flow Diverter Placement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success | Procedural success is defined as the full expansion of the Flowise identified on angiography and the full coverage of the targeted aneurysm neck in the absence of periprocedural stroke or death. | 5days | 
| ≥50% intracranial aneurysm size reduction success at 6 month | Intracranial aneurysm size is measured by Transfemoral Cerebral Angiography (TFCA). | 6months | 
| Aneurysm occlusion success at 6month | Aneurysm occlusion success is defined as Raymond class Ⅰ, Ⅱ | 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ≥50% Parent artery stenosis or occlusion |  | 6months | 
| Newly developed neurological disorder | Newly developed neurological disorder is defined as neurological problem lasts for at least 1 month post procedure and ≥3 modified Rankin Scale (mRS). | 6months | 
| Ipsilateral stroke | Ipsilateral stroke is defined as ≥5 according to the National Institute of Health Stroke Scale (NIHSS). | 6months | 
| 30-day death | 30-day death was defined as death within 30 days post procedure. | 6months | 
| Other adverse events |  | 6months |