International journal of stroke : official journal of the International Stroke Society · 2019
Randomization of endovascular treatment with stent-retriever and/or thromboaspiration versus best medical therapy in acute ischemic stroke due to large vessel occlusion trial: Rationale and design.
СтатьяПоддержка исследования: вне правительства СШАПротокол клинического исследованияНазвание и аннотация: Перевод пока не подготовлен
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Nogueira Raul G, Lima Fabricio O, Pontes-Neto Octávio M, S Silva Gisele, José Mont'Alverne Francisco, Abud Daniel G, Frudit Michel, Passos Paulo, Haussen Diogo C, Dabus Guilherme, de Freitas Gabriel R, Oliveira-Filho Jamary, Bezerra Daniel C, Liebeskind David S, Wagner Mario B, Passos José Ef, Molina Carlos A, Broderick Joseph, Saver Jeffrey L, Martins Sheila O
Аннотация
BACKGROUND: RESILIENT is a prospective, multicenter, randomized phase III trial to test the safety, efficacy, and cost-effectiveness of mechanical thrombectomy as compared to medical treatment alone in patients treated under the less than ideal conditions typically found in the public healthcare system of a developing country.
METHODS: Subjects must fulfill the following main inclusion criteria: symptom onset ≤8 h, age ≥18 years, baseline NIHSS ≥8, evidence of intracranial ICA or proximal MCA (M1 segment) occlusion, ASPECTS ≥6 on CT or >5 on DWI-MRI and be either ineligible for or unresponsive to intravenous alteplase. The primary end-point is the distribution of disability levels (on the modified Rankin Scale, mRS) at 90 days under the intention-to-treat principle.
RANDOMIZATION: Randomization is performed under a minimization process using age, baseline NIHSS, intravenous alteplase use, occlusion site and center.
DESIGN: The trial is designed with an expectation of a 10% difference in the proportion of favorable outcome (mRS 0-2 at 90 days) common odds ratio of 1.615.
PRIMARY OUTCOME: Projected sample size is 690 subjects with pre-planned interim analyses at 174, 346, and 518 subjects.
SECONDARY OUTCOMES: Secondary end-points include: 90-day functional independence (mRS ≤2), mRS shift stratified for treatment with IV rt-PA at 90 days, infarct volume on 24 h CT or MRI, early dramatic response (NIHSS 0-2 or improvement ≥8 points) at 24 h, vessel recanalization evaluated by CTA or MRA at 24 h, and the post-procedure rate of successful reperfusion (defined as a modified Treatment in Cerebral Infarction 2b or greater). Safety variables are mortality at 90 days, symptomatic intracranial hemorrhage at 24 h and procedure-related complications.
METHODS: Subjects must fulfill the following main inclusion criteria: symptom onset ≤8 h, age ≥18 years, baseline NIHSS ≥8, evidence of intracranial ICA or proximal MCA (M1 segment) occlusion, ASPECTS ≥6 on CT or >5 on DWI-MRI and be either ineligible for or unresponsive to intravenous alteplase. The primary end-point is the distribution of disability levels (on the modified Rankin Scale, mRS) at 90 days under the intention-to-treat principle.
RANDOMIZATION: Randomization is performed under a minimization process using age, baseline NIHSS, intravenous alteplase use, occlusion site and center.
DESIGN: The trial is designed with an expectation of a 10% difference in the proportion of favorable outcome (mRS 0-2 at 90 days) common odds ratio of 1.615.
PRIMARY OUTCOME: Projected sample size is 690 subjects with pre-planned interim analyses at 174, 346, and 518 subjects.
SECONDARY OUTCOMES: Secondary end-points include: 90-day functional independence (mRS ≤2), mRS shift stratified for treatment with IV rt-PA at 90 days, infarct volume on 24 h CT or MRI, early dramatic response (NIHSS 0-2 or improvement ≥8 points) at 24 h, vessel recanalization evaluated by CTA or MRA at 24 h, and the post-procedure rate of successful reperfusion (defined as a modified Treatment in Cerebral Infarction 2b or greater). Safety variables are mortality at 90 days, symptomatic intracranial hemorrhage at 24 h and procedure-related complications.