Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke

Phase 3

Terminated

• Conditions: Ischemic Stroke
• Interventions: Procedure: Endovascular thrombectomy/thrombolysis

• Registration Number: NCT01778335
• Lead Sponsor: University of Calgary

Brief Summary

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-25
• Study First Submitted QC: 2013-01-28
• Study First Posted: 2013-01-29
• Primary Completion: 2014-11
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-20
• Last Update Posted: 2015-03-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 316

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endovascular thrombectomy/thrombolysis	Endovascular thrombectomy/thrombolysis	Endovascular mechanical thrombectomy or endovascular delivery of thrombolytic agent

Primary Outcome Measures

Name	Time	Method
Shift in the mRS score, defined by a proportional odds model.	90 days

Secondary Outcome Measures

Name	Time	Method
Cognitive outcome - MOCA	90 days	Global test of cognitive function. Scale from 0 to 30 points.
Cognitive Outcome - Sunnybrook hemi-spatial neglect battery	90 days	Test of hemi-spatial neglect.
Cognitive outcome - Boston Naming Test	90 days	Test of language function
Cognitive outcome - Trailmaking A, B	90 days	Trailmaking A, B; Executive function task. Timed outcome as a continuous measure in seconds.
The proportion of patients who achieve a NIHSS score 0-2	90 days	Stroke severity. Clinical scale outcome score from 0 to 42.
The proportion of patients who achieve a mRS 0-2	90 days	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.
EQ5D	90 days	Quality of life. Clinical scale score as well as a visual analog scale of QOL from 0 to 100.
The proportion of patients who achieve a Barthel Index > 90	90 days	Activities of daily living. Clinical scale outcome score from 0 to 100.

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada