Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke "ESCAPE"

Terminated

Phase 3 Results N/A

Trial Description

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.

Detailed Description

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.

Conditions

Interventions

  • 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

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

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 EQ5D 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

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