Abstract
Background Present mechanical devices are unable to achieve recanalisation in up to 20-40% of large vessel occlusion strokes. We compared effi cacy and safety of the Trevo Retriever, a new stent-like device, with its US Food and Drug Administration-cleared predecessor, the Merci Retriever. Methods In this open-label randomised controlled trial, we recruited patients at 26 sites in the USA and one in Spain. We included adults aged 18-85 years with angiographically confirmed large vessel occlusion strokes and US National Institutes of Health Stroke Scale (NIHSS) scores of 8-29 within 8 h of symptom onset. We randomly assigned patients (1:1) with sequentially numbered sealed envelopes to thrombectomy with Trevo or Merci devices. Randomisation was stratified by age (≤68 years vs 69-85 years) and NIHSS scores (≤18 vs 19-29) with alternating blocks of various sizes. The primary efficacy endpoint, assessed by an unmasked core laboratory, was thrombolysis in cerebral infarction (TICI) scores of 2 or greater reperfusion with the assigned device alone. The primary safety endpoint was a composite of procedure-related adverse events. Analyses were done by intention to treat.
Original language | English (US) |
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Pages (from-to) | 1231-1240 |
Number of pages | 10 |
Journal | The Lancet |
Volume | 380 |
Issue number | 9849 |
DOIs | |
State | Published - Oct 2012 |
ASJC Scopus subject areas
- General Medicine