Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide-Neck Aneurysms – SCENT: 3-year outcomes
| Autor: | Ricardo A, Hanel, Gustavo M, Cortez, Alexander L, Coon, Peter, Kan, Philipp, Taussky, Ajay K, Wakhloo, Babu G, Welch, Aclan, Dogan, Mark, Bain, Joost, De Vries, Koji, Ebersole, Philip M, Meyers, E, Levy |
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| Rok vydání: | 2022 |
| Předmět: | |
| Zdroj: | Journal of NeuroInterventional Surgery. :jnis-2022 |
| ISSN: | 1759-8486 1759-8478 |
| Popis: | BackgroundTo 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).MethodsThe 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.ResultsOf 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).ConclusionThe present findings support the long-term safety and effectiveness of the Surpass Streamline flow diverter device.Trial registrationNCT01716117. |
| Databáze: | OpenAIRE |
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