دورية أكاديمية
Clinical Results of the Advanced Neurovascular Access Catheter System Combined With a Stent Retriever in Acute Ischemic Stroke (SOLONDA)
العنوان: | Clinical Results of the Advanced Neurovascular Access Catheter System Combined With a Stent Retriever in Acute Ischemic Stroke (SOLONDA) |
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المؤلفون: | Requena, Manuel, Ribó Gomis, Marc, Zamarro, Joaquin, Vega, Pedro, Blasco, Jordi, González, Eva María, Del Mar Freijo, María, Mendez Cendón, Jose Carlos, De Miquel, María Ángeles, Hernández, David, Moreu, Manuel, Remollo, Sebastià, Sánchez, Sonia, Liebeskind, David S., Andersson, Tommy, Cognard, Christophe, Nogueira, Raul, Tomasello, Alejandro |
المصدر: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
بيانات النشر: | Ovid Technologies (Wolters Kluwer Health) |
سنة النشر: | 2022 |
المجموعة: | Dipòsit Digital de la Universitat de Barcelona |
مصطلحات موضوعية: | Catèters, Reperfusió, Catheters, Reperfusion (Physiology) |
الوصف: | Background: The Advanced Neurovascular Access (ANA) thrombectomy system is a novel stroke thrombectomy device comprising a self-expanding funnel designed to reduce clot fragmentation by locally restricting flow while becoming as wide as the lodging artery. Once deployed, the ANA device allows distal aspiration combined with a stent retriever to mobilize the clot into the funnel where it remains copped during extraction. We investigated the safety and efficacy of ANA catheter system. Methods: SOLONDA (Solitaire in Combination With the ANA Catheter System as Manufactured by Anaconda) was a prospective, open, single-arm, multicenter trial with blinded assessment of the primary outcome by an independent core lab. Patients with anterior circulation vessel occlusion admitted within 8 hours from symptom onset were eligible. The primary end point was successful reperfusion (modified Thrombolysis in Cerebral Infarction score 2b-3) with <= 3 passes of the ANA device in combination with stent retriever, before the use of rescue therapy in the intention to treat population. Primary predefined analysis was noninferiority as compared to the performance end point observed in HERMES (High Effective Reperfusion Using Multiple Endovascular Devices). Results: After enrollment of 74 patients, an interim analysis was conducted, and the trial Steering Committee decided to terminate recruitment due to safety and performance objectives were reached. Mean age was 71.6 (SD 8.9) years, 46.6% women and median National Institutes of Health Stroke Scale on admission 14 (interquartile range, 10-19). Successful reperfusion within 3 passes before rescue therapy was achieved in 60/72 (83.3% [95% CI, 74.7%-91.9%]) with a rate of complete reperfusion (modified Thrombolysis in Cerebral Infarction score 2c-3) of 60% (95% CI, 48.4%-71.1%; 43/72 patients). After noninferiority was confirmed (P<0.01), the ANA device also showed superiority in the rate of successful reperfusion with |
نوع الوثيقة: | article in journal/newspaper |
وصف الملف: | 9 p.; application/pdf |
اللغة: | English |
تدمد: | 1524-4628 |
العلاقة: | Reproducció del document publicat a: https://doi.org/10.1161/STROKEAHA.121.037577Test; Stroke, 2022, vol. 53, núm. 7, p. 2211-2219; https://doi.org/10.1161/STROKEAHA.121.037577Test; http://hdl.handle.net/2445/189386Test |
الإتاحة: | https://doi.org/10.1161/STROKEAHA.121.037577Test http://hdl.handle.net/2445/189386Test |
حقوق: | cc by (c) Requena, Manuel et al., 2022 ; http://creativecommons.org/licenses/by/3.0/esTest/ ; info:eu-repo/semantics/openAccess |
رقم الانضمام: | edsbas.90D741E8 |
قاعدة البيانات: | BASE |
تدمد: | 15244628 |
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