Intracranial Aneurysm
Conditions
Brief summary
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
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.
Interventions
DEVICEFlowise Cerebral Flow Diverter
Flowise Cerebral Flow Diverter Placement
Sponsors
Yonsei University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success | 5days | 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. |
| ≥50% intracranial aneurysm size reduction success at 6 month | 6months | Intracranial aneurysm size is measured by Transfemoral Cerebral Angiography (TFCA). |
| Aneurysm occlusion success at 6month | 6months | Aneurysm occlusion success is defined as Raymond class Ⅰ, Ⅱ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-day death | 6months | 30-day death was defined as death within 30 days post procedure. |
| ≥50% Parent artery stenosis or occlusion | 6months | — |
| Other adverse events | 6months | — |
| Newly developed neurological disorder | 6months | Newly developed neurological disorder is defined as neurological problem lasts for at least 1 month post procedure and ≥3 modified Rankin Scale (mRS). |
| Ipsilateral stroke | 6months | Ipsilateral stroke is defined as ≥5 according to the National Institute of Health Stroke Scale (NIHSS). |
Countries
South Korea
Outcome results
None listed