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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Flowise Cerebral Flow Diverter Placement
Yonsei University Healthcare System, Severance Hospital
Seoul, Yeonsei-ro Seodaemun-gu, South Korea
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.
Time frame: 5days
≥50% intracranial aneurysm size reduction success at 6 month
Intracranial aneurysm size is measured by Transfemoral Cerebral Angiography (TFCA).
Time frame: 6months
Aneurysm occlusion success at 6month
Aneurysm occlusion success is defined as Raymond class Ⅰ, Ⅱ
Time frame: 6months
≥50% Parent artery stenosis or occlusion
Time frame: 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).
Time frame: 6months
Ipsilateral stroke
Ipsilateral stroke is defined as ≥5 according to the National Institute of Health Stroke Scale (NIHSS).
Time frame: 6months
30-day death
30-day death was defined as death within 30 days post procedure.
Time frame: 6months
Other adverse events
Time frame: 6months
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