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Lookup NU author(s): Professor Phil White,
Dr Barbara Gregson,
Dr Adela Cora,
Dr Anand Dixit,
Dr Rachel Lakey,
Dr Ahmed Maiter,
Professor Gary Ford
This is the authors' accepted manuscript of an article that has been published in its final definitive form by BMJ Publishing Group, 2020.
For re-use rights please refer to the publisher's terms and conditions.
© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.Background: Study was a PROBE design phase II randomized controlled trial (RCT). We assessed trial feasibility and technical efficacy and safety of two novel thrombectomy devices - ERIC (a retriever device) and SOFIA (a distal access catheter) - used alone or in combination depending on operator preference. Methods: Four UK neuroscience centers enrolled adults with proximal large artery occlusion (LAO) stroke on imaging where arterial puncture was achievable within 5.5 hours (8.5 hours for posterior circulation) of symptom onset; National Institutes of Health Stroke Scale (NIHSS) ≥6 with limited ischemic change on CT imaging. Randomization was 2:1 into intervention arm (ERIC and/or SOFIA). Patients and core lab were blinded to allocation. Primary outcome was independent core lab adjudication of reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) scale). Secondary outcomes were modified Rankin score (mRS) at 90 and 365 days (independence and shift analysis), 30-day mortality, symptomatic intracranial hemorrhage (sICH), procedural complications and NIHSS change. Results: Sixty-six patients were enrolled. TICI 2B/3 reperfusion was achieved in 72% in intervention compared with 90% in control arm on intention to treat (ITT) analysis (P=0.2) and 78% compared with 86% on per protocol analysis (P=0.7). Functional independence at 90 days was 40% (intervention) compared with 43% (control) on ITT analysis (P=1.0). sICH rates were low at 0% and 5%, respectively (P=0.3). The 30-day mortality was 9% intervention compared with 14% control (P=0.7). Conclusions: Study indicated feasibility of a phase II RCT trial approach for assessing new thrombectomy devices. In a broad LAO stroke population ERIC and SOFIA were not statistically different from control devices. Larger trials are needed.
Author(s): White PM, Gregson B, Cora EA, Dixit A, Subramanian G, Joshi Y, Simister R, Lakey R, Maiter A, Ford GA
Publication type: Article
Publication status: Published
Journal: Journal of NeuroInterventional Surgery
Pages: epub ahead of print
Online publication date: 14/07/2020
Acceptance date: 17/06/2020
Date deposited: 18/08/2020
ISSN (print): 1759-8478
ISSN (electronic): 1759-8486
Publisher: BMJ Publishing Group
PubMed id: 32665431
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