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.
Trial Stopped: On DSMB advice, trial recruitment has been halted for efficacy. F/U continues.
- Endovascular thrombectomy/thrombolysis Procedure
Other Names: Endovascular mechanical thrombectomy Intervention Desc: Endovascular mechanical thrombectomy or thrombolysis ARM 1: Kind: Experimental Label: Endovascular thrombectomy/thrombolysis Description: Endovascular mechanical thrombectomy or endovascular delivery of thrombolytic agent
- Allocation: Randomized
- Masking: Single Blind (Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||The proportion of patients who achieve a NIHSS score of 0-2 OR a mRS score of 0-2 at 90 days.||90 days||No|
|Secondary||NIHSS score||90 days||No|
|Secondary||mRS score||90 days||No|
|Secondary||Barthel Index||90 days||No|
|Secondary||Cognitive outcomes||90 days||No|
|Primary||Shift in the mRS score, defined by a proportional odds model.||90 days||No|
|Secondary||The proportion of patients who achieve a NIHSS score 0-2||90 days||No|
|Secondary||The proportion of patients who achieve a mRS 0-2||90 days||No|
|Secondary||The proportion of patients who achieve a Barthel Index > 90||90 days||No|
|Secondary||Cognitive outcome - Trailmaking A, B||90 days||No|
|Secondary||Cognitive outcome - MOCA||90 days||No|
|Secondary||Cognitive outcome - Boston Naming Test||90 days||No|
|Secondary||Cognitive Outcome - Sunnybrook hemi-spatial neglect battery||90 days||No|