| OBJECTIVES | To determine the efficacy and safety of mechanical thrombectomy plus best medical treatment compared to best medical treatment alone in patients with large acute ischemic stroke with ASPECTS 0–5 and large vessel occlusion of the anterior circulation. |
| STUDY | International, multicenter, prospectively randomized into two parallel (1:1) arms, open-label, with blinded endpoint (PROBE design) trial across 36 centers in France, Spain, and the United States. |
| POPULATION | Patients ≥18 years of age (no upper age limit) presenting acute ischemic stroke, pre-stroke mRS ≥1, baseline ASPECTS 0-5 or 4-5 for ≥80 years of age patients, assessed with non-contrast CT or DWI MRI, within 6.5 hours of last-seen-well (or negative FLAIR) if unknown stroke onset time, and anterior circulation LVO (Intracranial ICA, M1 or M1-M2) on CTA or MRA. |
| ENDPOINTS | The primary endpoint is the day-90 mRS score distribution (shift analysis) with mRS categories 5 and 6 coalesced into one category. Secondary endpoints included 180-day mRS score, rates of 90-day and 180-day mRS score=0–2 and 0–3, NIHSS score change, infarct volume growth at 24 hours, among others. |