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.
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Contributors PMW and GAF designed the trial, obtained funding, and were Co-Chief Investigators. EAC and PMW obtained ethical approval. BG was trial statistician. EAC and PMW with RL coordinated follow-up. PMW, EAC, BG, GAF and AM drafted the manuscript. All authors revised the manuscript for important intellectual content. AD, JY, GS and RS were local Principal Investigators, recruited patients and directed data accrual.
Funding The funders (equal co-funders were Newcastle University Biomedical Research Centre and Microvention Terumo) had no control over study design, data collection, data analysis, interpretation or writing of this report, or the decision to publish.
Competing interests PMW reports personal fees from Stryker Global Advisory Board on Haemorrhagic Stroke and MicroVention-Terumo and institutional grants from Medtronic, Stryker, Penumbra, Stroke Association, British Heart Foundation and National Institute for Health Research outside the submitted work. GAF reports personal fees from Stryker and personal fees from Medtronic, Daichi Sankyo, Bayer Amgen outside the submitted work. RS is part-funded by the UCLH/UCL Biomedical Research Centre. BG, EAC, AM, AD, GS, YJ and RL have nothing to disclose.
Patient consent for publication Not required.
Ethics approval Written informed patient consent/assent was obtained and multicenter ethics approval was obtained (North East England REC A Ref. 14/NE/0113).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request. Fully anonymised data from this trial will be available to the scientific community subject to appropriate ethics approval and Trial Steering Committee agreement. Requests for anonymised data should be directed to the Chief Investigator. Trial protocol can be obtained via Newcastle University Clinical Trials Unit. Ultimately the authors intend to seek permission to archive data in the VISTA Thrombectomy repository.