http://www.docguide.com/multicenter-randomized-controlled-trial-endovascular-therapy-following-imaging-evaluation-ischemic-s?
Tuesday, November 7, 2017
A multicenter randomized controlled trial of endovascular therapy following imaging evaluation for ischemic stroke (DEFUSE 3)
What should occur with research like this is it points to the previous stroke protocol and shows what needs to change to make it better, But NO, we have multiple very similar research studies covering the same ground but never writing up a stroke protocol. Their mentors should ream them out for such sloppy incomplete work.
http://www.docguide.com/multicenter-randomized-controlled-trial-endovascular-therapy-following-imaging-evaluation-ischemic-s?
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).
http://www.docguide.com/multicenter-randomized-controlled-trial-endovascular-therapy-following-imaging-evaluation-ischemic-s?
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