Randomization of endovascular treatment with stent-retriever and/or thromboaspiration versus best medical therapy in acute ischemic stroke due to large vessel occlusion in the extended time window trial (RESILIENT-Extend): Rationale and design
Year: 2026
Type: article
Study design: Study Protocol
Abstract: BACKGROUND: Randomized trials have demonstrated substantial benefit of mechanical thrombectomy (MT) in selected patients treated 6-24 h after stroke onset. However, these trials relied on advanced imaging not typically available in resource-constrained settings. The RESILIENT-Extend trial aims to evaluate the efficacy and safety of MT in the 8- to 24-h window using a pragmatic imaging selection based on non-contrast computed tomography (CT) and CT angiography alone. METHODS: RESILIENT-Extend is a multicenter, randomized, controlled, open-label, blinded-endpoint, phase 3 trial conducted in Brazil. The planned sample size is 376 participants. Patients presenting with anterior-circulation large vessel occlusion within 8-24 h from time last known well will be randomized 1:1 to receive either MT plus best medical management (BMM) or BMM alone. The trial uses a minimization algorithm to balance prognostic variables including age, National Institutes of Health Stroke Scale (NIHSS), Alberta Stroke Program Early CT Score (ASPECTS), occlusion site, time window, and clinical site. The primary outcome is the distribution of 90-day modified Rankin Scale scores assessed by blinded central adjudication. DISCUSSION: RESILIENT-Extend is one of the first randomized trials to evaluate MT in the extended window using a pragmatic selection strategy based exclusively on widely available imaging modalities (non-contrast CT and CT angiography), with a focus on scalability in real-world and resource-constrained settings. TRIAL REGISTRATION: clinicaltrials.govNCT04256096.
Source: International Journal of Stroke
Institutions: Universidade Federal do Rio Grande do Sul, Hospital Moinhos de Vento, Hospital de Clínicas de Porto Alegre, Hospital Israelita Albert Einstein, Universidade Federal de São Paulo, Hospital Geral de Fortaleza, Hospital de Base, Universidade de Fortaleza, Universidade de São Paulo, Clinics Hospital of Ribeirão Preto, Universidade Federal da Bahia, Hospital Pró-Cardíaco, University of Pittsburgh, UPMC Health System, University of Pittsburgh Medical Center
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Funders: Medtronic, Penumbra, Ministério da Saúde
Award: G5042468421
OpenAlex ID: W7169592447
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