A phase III, randomized, multi-center, open label clinical trial that will examine whether endovascular treatment is superior to standard medical therapy alone in patients who suffer a large vessel anterior circulation ischemic stroke within 8-24 hours from time last seen well
Prospective, multi-center, randomized, controlled, open-label, blinded-endpoint trial with a sequential design. The randomization employs a 1:1 ratio of mechanical thrombectomy with stent-retriever and/or thromboaspiration versus medical management alone in patients who suffer a large vessel anterior circulation ischemic stroke between 8 and 24 hours from time last seen well. Randomization will be done under a minimization process using age (≤68 vs. \>68 years), baseline NIHSS (\<17 v. ≥17), ASPECTS (5-7 vs. 8-10), therapeutic window (6-12 or 12-24 hours after TLKW), occlusion site (Intracranial ICA or M1), and clinical site. For the primary endpoint, subjects will be followed for 90 days post-randomization. Sham endovascular procedure has been rejected due to the medical risk of the angiography and practical issues that difficult to maintain blindness of investigators.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
376
Endovascular treatment of large vessel occlusion (mechanical thrombectomy) with stent-retriever and/or thromboaspiration (neurointerventionalist choice)
Hospital Geral de Fortaleza
Fortaleza, Ceará, Brazil
RECRUITINGAssociacao Congregacao de Santa Catarina
Vitória, Espírito Santo, Brazil
Modified Rankin Scale scores
Distribution of the modified Rankin Scale scores at 90 days (shift analysis). The score range from zero to 6 with higher values indicating a worst functional outcome at 90 days
Time frame: 90 days
Proportion of Patients with Functional independence in 90 days
Functional independence defined as mRS ≤2
Time frame: 90 days
Disability on the utility-weighted modified Rankin scale (UW-mRS)
Mean score for disability on the utility-weighted modified Rankin scale (UW-mRS). The score range from 1 to zero with higher values indicating a better functional outcome at 90 days
Time frame: 90 days
Quality of life measured by EuroQol Group 5-Dimension Self-Report Questionnaire (EuroQol / EQ5D)
Quality of life analysis as measured by EuroQol/EQ5D 5-Dimension Self-Report Questionnaire, on which scores range from -0.176 to 1, with higher values indicating a better quality of life\]) at 90 days
Time frame: 90 days and 1 year
Mortality at 90 days
Mortality at 90 days
Time frame: 90 days
Proportion of patients with Intracranial Hemorrhage at 24 hours
Clinically significant ICH rates at 24 (-2/+12) hours. All intracerebral hemorrhages will be classified by a central core-lab using the Heidelberg criteria. Symptomatic ICH will be defined as per the SITS-MOST definition: deterioration in NIHSS score of ≥4 points within 24 hours from treatment and evidence of intraparenchymal hemorrhage type 2 in the 22 to 36 hours follow-up imaging scans.
Time frame: 24 hours
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Hospital de Base
Brasília, Federal District, Brazil
RECRUITINGHospital das Clínicas de Uberlândia
Uberlândia, Minas Gerais, Brazil
RECRUITINGHospital de Clínicas da Universidade Federal do Paraná
Curitiba, Paraná, Brazil
NOT_YET_RECRUITINGConferencia Sao jose do Avai
Itaperuna, Rio de Janeiro, Brazil
NOT_YET_RECRUITINGHospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
RECRUITINGIrmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA
Porto Alegre, Rio Grande do Sul, Brazil
NOT_YET_RECRUITINGHospital das Clínicas da Faculdade de Medicina de Botucatu
Botucatu, São Paulo, Brazil
NOT_YET_RECRUITINGHospital de Clínicas - UNICAMP
Campinas, São Paulo, Brazil
NOT_YET_RECRUITING...and 4 more locations
Procedural related complications
Procedural related complications: arterial perforation, arterial dissection, and embolization in a previously uninvolved vascular territory
Time frame: immediately after procedure