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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flowise Cerebral Flow Diverter | Experimental | Flowise Cerebral Flow Diverter (TaeWoong Medical Co., Ltd. Korea) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flowise Cerebral Flow Diverter | Device | Flowise Cerebral Flow Diverter Placement |
|
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Buyng Moon Kim, PhD. MD | Yonsei University Healthcare System, Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Healthcare System, Severance Hospital | Seoul | Yeonsei-ro Seodaemun-gu | 03722 | South Korea |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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 |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |