Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide-Neck Aneurysms - SCENT: 3-year outcomes
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Publication year
2023Source
Journal of NeuroInterventional Surgery, 15, 11, (2023), pp. 1084-1089ISSN
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Article / Letter to editor
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Organization
Neurosurgery
Journal title
Journal of NeuroInterventional Surgery
Volume
vol. 15
Issue
iss. 11
Page start
p. 1084
Page end
p. 1089
Subject
Radboudumc 16: Vascular damage Neurosurgery; Neurosurgery - Radboud University Medical CenterAbstract
BACKGROUND: To report the 3-year safety and effectiveness of the Surpass Streamline flow diverter in the SCENT trial (Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide-Neck Aneurysms). METHODS: The Surpass Streamline flow diverter device was evaluated in a multicenter, prospective, single-arm, non-randomized interventional trial including patients with uncoilable or previously treated but failed aneurysms of the intracranial internal carotid artery. 3-year outcomes were tabulated with descriptive statistics and compared with 1-year outcomes. RESULTS: Of 180 patients in the modified intent-to-treat (mITT) cohort, 36-month clinical and angiographic follow-up was available in 134 and 117 cases, respectively. Effectiveness endpoint of complete aneurysm occlusion without clinically significant stenosis or retreatment was met in 71.8% (79/110, 95% CI 62.4% to 80.0%) of cases. Safety composite endpoint was 12.2% (22/180) over the 3-year period, with two major safety events (ipsilateral ischemic strokes) occurring between 12-36 months. Complete aneurysm occlusion was noted in 77.8% (91/117), and 99.1% (116/117) of the patients demonstrated adequate aneurysm occlusion (complete occlusion or neck residual). There were four cases (2.2%) of aneurysm rupture, all occurring within the first month of the index procedure. Target aneurysm retreatment rate was 2.8% (5/180). CONCLUSION: The present findings support the long-term safety and effectiveness of the Surpass Streamline flow diverter device. TRIAL REGISTRATION: NCT01716117.
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