Abstract WMP87: Primary Results From The CLEAR Study Of The Safety And Effectiveness Of The Neva Stent Retriever For Large Vessel Thrombectomy
| Autor: | Albert J Yoo, Serdar Geyik, Michael Froehler, Christoph Maurer, Tareq Kass-Hout, Osama Zaidat, Raul G Nogueira, Ricardo Hanel, Laurent Pierot, Laurent Spelle, Demetrius Lopes, Ameer E Hassan, Audrius Sirvinskas, Eugene Lin, Marc Ribo, Jordi Blasco, Muhammad Taqi, Aamir Badruddin, Adnan H Siddiqui, Timothy R Miller, Muhammad Hussain, Diogo C Haussen, Keith Woodward, Christoph Groden, Arturo Consoli, Imran Chaudry, Christian Ramsey, Alberto Maud, Joshua Bentley, Waleed Brinjikji, Arsida Bajrami, Maher Sahnoun, Jens Fiehler, Rishi Gupta |
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| Rok vydání: | 2023 |
| Předmět: | |
| Zdroj: | Stroke. 54 |
| ISSN: | 1524-4628 0039-2499 |
| DOI: | 10.1161/str.54.suppl_1.wmp87 |
| Popis: | Despite the proven benefit of stent retrievers, challenges to rapid revascularization of large vessel occlusions (LVO) persist. Current stent retrievers have limited effectiveness for removing organized thrombi. The NeVa device is a novel stent retriever designed with openings in the basket cell structure (“drop zones”) intended to capture organized thrombi within the central scaffold during retrieval. Prospective, multicenter, open label, single arm, FDA-regulated IDE study to evaluate the performance of the NeVa device for recanalizing occluded intracranial vessels including ICA, M1/M2 MCA, and vertebrobasilar arteries, within 8 hours of onset. Primary endpoint was rate of eTICI 2b-3 within 3 NeVa passes, tested for non-inferiority against a performance goal of 72% with a margin of -10%. Additional efficacy endpoints included first pass effect to eTICI 2b-3 (FPE) and 90-day mRS 0-2. Primary safety endpoint was 90-day mortality. (ClinicalTrials.gov NCT04514562) (Site-adjudicated revascularization results are reported here. Final core lab results will be presented at the conference.) From April 1, 2021 to April 28, 2022, 139 subjects were enrolled at 25 centers in the US and Europe. Mean age was 67 ± 13 years; 47% were female. Median NIHSS score was 16 (IQR: 12-20). Occlusions were 14 (10%) ICA, 85 (61%) M1, 38 (27%) M2, 1 (1%) Basilar and 1 (1%) PCA. Mean time to first pass was 19 ± 12 minutes. eTICI 2b-3 within 3 NeVa passes occurred in 87.8% (122/139; CI 81.1%,92.7%; non-inferiority p |
| Databáze: | OpenAIRE |
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