A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of Flowise Cerebral Flow Diverter (Flowise)
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|ClinicalTrials.gov Identifier: NCT02609867|
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : July 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Aneurysm||Device: Flowise Cerebral Flow Diverter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||October 23, 2015|
|Actual Primary Completion Date :||January 22, 2018|
|Actual Study Completion Date :||January 22, 2018|
Experimental: Flowise Cerebral Flow Diverter
Flowise Cerebral Flow Diverter (TaeWoong Medical Co., Ltd. Korea)
Device: Flowise Cerebral Flow Diverter
Flowise Cerebral Flow Diverter Placement
- 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).
- Aneurysm occlusion success at 6month [ Time Frame: 6months ]Aneurysm occlusion success is defined as Raymond class Ⅰ, Ⅱ
- ≥50% Parent artery stenosis or occlusion [ Time Frame: 6months ]
- Newly developed neurological disorder [ Time Frame: 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 [ Time Frame: 6months ]Ipsilateral stroke is defined as ≥5 according to the National Institute of Health Stroke Scale (NIHSS).
- 30-day death [ Time Frame: 6months ]30-day death was defined as death within 30 days post procedure.
- Other adverse events [ Time Frame: 6months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609867
|Korea, Republic of|
|Yonsei University Healthcare System, Severance Hospital|
|Seoul, Yeonsei-ro Seodaemun-gu, Korea, Republic of, 03722|
|Principal Investigator:||Buyng Moon Kim, PhD. MD||Yonsei University Healthcare System, Severance Hospital|