The purpose of the study is to understand whether a new treatment of stroke - endovascular clot removal - can be added to the current standard of care to improve patient outcomes. All patients will receive the best standard stroke treatment. This includes treating patients with the clot dissolving drug tPA (tissue plasminogen activator). However, t-PA does not work in some patients and others are not eligible to receive t-PA because they present too late for treatment (they woke up with their stroke symptoms or their stroke was not witnessed). During endovascular revascularization the blockage in the artery is removed with the use of devices called stentreivers and or by giving clot dissolving drug at the site of the blockage in the artery to restore blood flow. Stentrievers are devices that have been designed by different companies to remove blood clots from arteries. Up to a maximum of 500 people at 20-25 hospitals across Canada and other countries will participate in this study.
ESCAPE is a phase 3, randomized, open-label with blinded outcome evaluation, controlled, parallel group design. The primary objectives of this study are to show that rapid endovascular revascularization amongst radiologically selected (small core/proximal occlusion) patients with ischemic stroke results in improved outcome compared to patients treated in clinical routine. Eligible patients will be enrolled within 12 hours of last seen normal with a baseline NIHSS \> 5 at the time of randomization. There must be a confirmed symptomatic intracranial occlusion, based on single phase, multiphase or dynamic CTA, at one or more of the following locations: Carotid T/L, M1 MCA, or M1-MCA equivalent (2 or more M2-MCAs). Anterior temporal artery is not considered an M2. All patients will receive the best standard of medical care according to modern acute stroke care guidelines. Control arm subjects will receive best medical care. In the intervention/experimental arm, subjects will be treated with endovascular thrombectomy or thrombolysis using currently available technology for use in the ESCAPE site for thrombectomy/thrombolysis. This study consists of one 90-day study period for each subject. Subjects will be hospitalized for care after their acute stroke according to the current standard of care. Subjects are required to return to clinic on Days 30 \& 90 for end-of-study procedures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
316
Endovascular mechanical thrombectomy or thrombolysis
University of Calgary
Calgary, Alberta, Canada
Shift in the mRS score, defined by a proportional odds model.
Time frame: 90 days
The proportion of patients who achieve a NIHSS score 0-2
Stroke severity. Clinical scale outcome score from 0 to 42.
Time frame: 90 days
The proportion of patients who achieve a mRS 0-2
Functional outcome. Dichotomous outcome, reported as independent (mRS 0-2) vs dependence or death (mRS 3-6). In addition, shift analysis (proportional odds model) representing the odds of improvement on within the scale with treatment.
Time frame: 90 days
The proportion of patients who achieve a Barthel Index > 90
Activities of daily living. Clinical scale outcome score from 0 to 100.
Time frame: 90 days
EQ5D
Quality of life. Clinical scale score as well as a visual analog scale of QOL from 0 to 100.
Time frame: 90 days
Cognitive outcome - Trailmaking A, B
Trailmaking A, B; Executive function task. Timed outcome as a continuous measure in seconds.
Time frame: 90 days
Cognitive outcome - MOCA
Global test of cognitive function. Scale from 0 to 30 points.
Time frame: 90 days
Cognitive outcome - Boston Naming Test
Test of language function
Time frame: 90 days
Cognitive Outcome - Sunnybrook hemi-spatial neglect battery
Test of hemi-spatial neglect.
Time frame: 90 days
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