• J Neurointerv Surg · Oct 2014

    Multicenter Study

    North American Solitaire Stent Retriever Acute Stroke registry: post-marketing revascularization and clinical outcome results.

    • Osama O Zaidat, Alicia C Castonguay, Rishi Gupta, Chung-Huan J Sun, Coleman Martin, William E Holloway, Nils Mueller-Kronast, Joey D English, Italo Linfante, Guilherme Dabus, Tim W Malisch, Franklin A Marden, Hormozd Bozorgchami, Andrew Xavier, Ansaar T Rai, Michael T Froehler, Aamir Badruddin, Thanh N Nguyen, M Asif Taqi, Michael G Abraham, Vallabh Janardhan, Hashem Shaltoni, Roberta Novakovic, Albert J Yoo, Alex Abou-Chebl, Peng R Chen, Gavin W Britz, Ritesh Kaushal, Ashish Nanda, Mohammad A Issa, and Raul G Nogueira.
    • Department of Neurology, Medical College of Wisconsin/Froedtert Hospital, Milwaukee, Wisconsin, USA Department of Neurosurgery, Medical College of Wisconsin/Froedtert Hospital, Milwaukee, Wisconsin, USA Department of Radiology, Medical College of Wisconsin/Froedtert Hospital, Milwaukee, Wisconsin, USA.
    • J Neurointerv Surg. 2014 Oct 1;6(8):584-8.

    BackgroundLimited post-marketing data exist on the use of the Solitaire FR device in clinical practice. The North American Solitaire Stent Retriever Acute Stroke (NASA) registry aimed to assess the real world performance of the Solitaire FR device in contrast with the results from the SWIFT (Solitaire with the Intention for Thrombectomy) and TREVO 2 (Trevo versus Merci retrievers for thrombectomy revascularization of large vessel occlusions in acute ischemic stroke) trials.MethodsThe investigator initiated NASA registry recruited North American sites to submit retrospective angiographic and clinical outcome data on consecutive acute ischemic stroke (AIS) patients treated with the Solitaire FR between March 2012 and February 2013. The primary outcome was a Thrombolysis in Myocardial Ischemia (TIMI) score of ≥2 or a Treatment in Cerebral Infarction (TICI) score of ≥2a. Secondary outcomes were 90 day modified Rankin Scale (mRS) score, mortality, and symptomatic intracranial hemorrhage.Results354 patients underwent treatment for AIS using the Solitaire FR device in 24 centers. Mean time from onset to groin puncture was 363.4±239 min, mean fluoroscopy time was 32.9±25.7 min, and mean procedure time was 100.9±57.8 min. Recanalization outcome: TIMI ≥2 rate of 83.3% (315/354) and TICI ≥2a rate of 87.5% (310/354) compared with the operator reported TIMI ≥2 rate of 83% in SWIFT and TICI ≥2a rate of 85% in TREVO 2.Clinical Outcome42% (132/315) of NASA patients demonstrated a 90 day mRS ≤2 compared with 37% (SWIFT) and 40% (TREVO 2). 90 day mortality was 30.2% (95/315) versus 17.2% (SWIFT) and 29% (TREVO 2).ConclusionsThe NASA registry demonstrated that the Solitaire FR device performance in clinical practice is comparable with the SWIFT and TREVO 2 trial results.Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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