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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Intracranial Aneurysm
- Sponsor
- Yonsei University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Aneurysm occlusion success at 6month
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Aneurysm occlusion success at 6month
Time Frame: 6months
Aneurysm occlusion success is defined as Raymond class Ⅰ, Ⅱ
Procedural success
Time Frame: 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
Time Frame: 6months
Intracranial aneurysm size is measured by Transfemoral Cerebral Angiography (TFCA).
Secondary Outcomes
- ≥50% Parent artery stenosis or occlusion(6months)
- Newly developed neurological disorder(6months)
- Ipsilateral stroke(6months)
- 30-day death(6months)
- Other adverse events(6months)