A multicenter randomized controlled trial of endovascular therapy following imaging evaluation for ischemic stroke (DEFUSE 3)
- 24 March 2017
- journal article
- research article
- Published by SAGE Publications in International Journal of Stroke
- Vol. 12 (8), 896-905
- https://doi.org/10.1177/1747493017701147
Abstract
Rationale: Early reperfusion in patients experiencing acute ischemic stroke is effective in patients with large vessel occlusion. No randomized data are available regarding the safety and efficacy of endovascular therapy beyond 6 h from symptom onset. Aim: The aim of the study is to demonstrate that, among patients with large vessel anterior circulation occlusion who have a favorable imaging profile on computed tomography perfusion or magnetic resonance imaging, endovascular therapy with a Food and Drug Administration 510 K-cleared mechanical thrombectomy device reduces the degree of disability three months post stroke. Design: The study is a prospective, randomized, multicenter, phase III, adaptive, blinded endpoint, controlled trial. A maximum of 476 patients will be randomized and treated between 6 and 16 h of symptom onset. Procedures: Patients undergo imaging with computed tomography perfusion or magnetic resonance diffusion/perfusion, and automated software (RAPID) determines if the Target Mismatch Profile is present. Patients who meet both clinical and imaging selection criteria are randomized 1:1 to endovascular therapy plus medical management or medical management alone. The individual endovascular therapist chooses the specific device (or devices) employed. Study outcomes: The primary endpoint is the distribution of scores on the modified Rankin Scale at day 90. The secondary endpoint is the proportion of patients with modified Rankin Scale 0–2 at day 90 (indicating functional independence). Analysis: Statistical analysis for the primary endpoint will be conducted using a normal approximation of the Wilcoxon–Mann–Whitney test (the generalized likelihood ratio test).Keywords
This publication has 25 references indexed in Scilit:
- Prospective, Multicenter, Single-Arm Study of Mechanical Thrombectomy Using Solitaire Flow Restoration in Acute Ischemic StrokeStroke, 2013
- MRI profile and response to endovascular reperfusion after stroke (DEFUSE 2): a prospective cohort studyThe Lancet Neurology, 2012
- Trevo versus Merci retrievers for thrombectomy revascularisation of large vessel occlusions in acute ischaemic stroke (TREVO 2): a randomised trialThe Lancet, 2012
- Assessing Response to Stroke ThrombolysisArchives of Neurology, 2012
- The Infarct Core is Well Represented by the Acute Diffusion Lesion: Sustained Reversal is InfrequentJournal of Cerebral Blood Flow & Metabolism, 2011
- Real‐time diffusion‐perfusion mismatch analysis in acute strokeJournal of Magnetic Resonance Imaging, 2010
- Magnetic resonance imaging profiles predict clinical response to early reperfusion: The diffusion and perfusion imaging evaluation for understanding stroke evolution (DEFUSE) studyAnnals of Neurology, 2006
- Power, sample size and adaptation considerations in the design of group sequential clinical trialsBiometrika, 2004
- Recombinant tissue plasminogen activator in acute thrombotic and embolic strokeAnnals of Neurology, 1992
- Intravenous recombinant tissue plasminogen activator in acute carotid artery territory strokeNeurology, 1992