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A Newly-Developed Flow Diverter (FloWise) for Internal Carotid Artery Aneurysm: Results of a Pilot Clinical Study
DC Field | Value | Language |
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dc.contributor.author | 이재환 | - |
dc.contributor.author | 정준호 | - |
dc.date.accessioned | 2019-05-29T05:18:46Z | - |
dc.date.available | 2019-05-29T05:18:46Z | - |
dc.date.issued | 2019 | - |
dc.identifier.issn | 1229-6929 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/169523 | - |
dc.description.abstract | OBJECTIVE: We report the results of a pilot clinical study that evaluated the safety and efficacy of a newly-developed, retrievable flow diverter (FloWise; Taewoong Medical) for the treatment of internal carotid artery (ICA) aneurysm. MATERIALS AND METHODS: A total of 10 patients were enrolled. Inclusion criteria were 1) unruptured aneurysm with a dome size of ≥ 8 mm and a neck size of ≥ 4 mm at the ICA, or 2) two or more unruptured aneurysms of any size able to be spanned by a single FloWise at the ICA. Co-primary effectiveness end points were technical success of FloWise placement, and a 50% or greater decrease in aneurysm volume at the 6-month follow-up angiogram. The primary safety end point was the new development of neurological deficits persisting for more than 1-month post-treatment. RESULTS: Ten patients harboring 14 ICA aneurysms (median diameter, 9.4 mm; range, 2.3-31.0 mm) were enrolled between January 2016 and July 2017. FloWise placement was successful in all patients. There were no newly-developed neurological deficits during the 6-month clinical follow-up period. One patient did not receive follow-up imaging due to pregnancy. Nine patients with 12 aneurysms received a 6-month angiographic follow-up. Ten aneurysms (83.3%) showed decreases in volume greater than 50% (mean volume decrease, 82.8 ± 32.9%), of which 8 (66.7%, 95% confidence interval, 35.4-98.0%) showed complete occlusion. One patient was retreated due to mass symptom aggravation. CONCLUSIONS: In this pilot study, FloWise appeared to be safe and effective for ICA aneurysm treatment. A prospective multicenter study to validate the effectiveness and safety of FloWise would be worthwhile. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Korean Society of Radiology | - |
dc.relation.isPartOf | KOREAN JOURNAL OF RADIOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.title | A Newly-Developed Flow Diverter (FloWise) for Internal Carotid Artery Aneurysm: Results of a Pilot Clinical Study | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Neurosurgery (신경외과학교실) | - |
dc.contributor.googleauthor | Byung Moon Kim | - |
dc.contributor.googleauthor | Keun Young Park | - |
dc.contributor.googleauthor | Jae Whan Lee | - |
dc.contributor.googleauthor | Joonho Chung | - |
dc.contributor.googleauthor | Dong Joon Kim | - |
dc.contributor.googleauthor | Dong Ik Kim | - |
dc.identifier.doi | 10.3348/kjr.2018.0421 | - |
dc.contributor.localId | A03088 | - |
dc.contributor.localId | A03731 | - |
dc.relation.journalcode | J02884 | - |
dc.identifier.eissn | 2005-8330 | - |
dc.identifier.pmid | 30799582 | - |
dc.subject.keyword | Flow diversion | - |
dc.subject.keyword | Intracranial aneurysm | - |
dc.subject.keyword | New device | - |
dc.contributor.alternativeName | Lee, Jae Whan | - |
dc.contributor.affiliatedAuthor | 이재환 | - |
dc.contributor.affiliatedAuthor | 정준호 | - |
dc.citation.volume | 20 | - |
dc.citation.number | 3 | - |
dc.citation.startPage | 505 | - |
dc.citation.endPage | 512 | - |
dc.identifier.bibliographicCitation | KOREAN JOURNAL OF RADIOLOGY, Vol.20(3) : 505-512, 2019 | - |
dc.identifier.rimsid | 62585 | - |
dc.type.rims | ART | - |
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