Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT01778335
Status:
TERMINATED
Last Update Posted:
2015-03-23
First Post:
2013-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke
Sponsor:
University of Calgary
Organization:
Study Overview
Official Title:
Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times (ESCAPE) Trial
Status:
TERMINATED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
On DSMB advice, trial recruitment has been halted for efficacy. F/U continues.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESCAPE
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: