Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE)
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.
Procedure: Endovascular thrombectomy/thrombolysis
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times (ESCAPE) Trial|
- Shift in the mRS score, defined by a proportional odds model. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- The proportion of patients who achieve a NIHSS score 0-2 [ Time Frame: 90 days ] [ Designated as safety issue: No ]Stroke severity. Clinical scale outcome score from 0 to 42.
- The proportion of patients who achieve a mRS 0-2 [ Time Frame: 90 days ] [ Designated as safety issue: No ]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.
- The proportion of patients who achieve a Barthel Index > 90 [ Time Frame: 90 days ] [ Designated as safety issue: No ]Activities of daily living. Clinical scale outcome score from 0 to 100.
- EQ5D [ Time Frame: 90 days ] [ Designated as safety issue: No ]Quality of life. Clinical scale score as well as a visual analog scale of QOL from 0 to 100.
- Cognitive outcome - Trailmaking A, B [ Time Frame: 90 days ] [ Designated as safety issue: No ]Trailmaking A, B; Executive function task. Timed outcome as a continuous measure in seconds.
- Cognitive outcome - MOCA [ Time Frame: 90 days ] [ Designated as safety issue: No ]Global test of cognitive function. Scale from 0 to 30 points.
- Cognitive outcome - Boston Naming Test [ Time Frame: 90 days ] [ Designated as safety issue: No ]Test of language function
- Cognitive Outcome - Sunnybrook hemi-spatial neglect battery [ Time Frame: 90 days ] [ Designated as safety issue: No ]Test of hemi-spatial neglect.
- The proportion of patients who suffer a Safety Outcome [ Time Frame: 0-90 days ] [ Designated as safety issue: Yes ]The proportion of patients with the composite of: (i) symptomatic intracranial hemorrhage (ii) major bleeding due to femoral artery access complications including groin hematoma, retroperitoneal hematoma (iii) contrast nephropathy.
- Economic (cost-effectiveness) analysis [ Time Frame: 90 days ] [ Designated as safety issue: No ]Economic analysis
- Evaluation of waiver/deferral of consent process [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]Qualitative evaluation of the waiver/deferral of consent process
- Safety - Other [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
(i) The total radiation dose (CT, CTA, angiography) reported as a continuous measure.
(ii) The proportion of patients with malignant MCA infarction (iii) The proportion of patients undergoing hemicraniectomy.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
No Intervention: Control
Control arm subjects will receive best medical care.
Experimental: Endovascular thrombectomy/thrombolysis
Endovascular mechanical thrombectomy or endovascular delivery of thrombolytic agent
Procedure: Endovascular thrombectomy/thrombolysis
Endovascular mechanical thrombectomy or thrombolysis
Other Name: Endovascular mechanical thrombectomy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778335
|University of Calgary|
|Calgary, Alberta, Canada, T2N2T9|
|Principal Investigator:||MIchael D Hill, MD MSc FRCPC||University of Calgary|
|Study Director:||Andrew M Demchuk, MD FRCPC||University of Calgary|
|Study Director:||Mayank Goyal, MD FRCPC||University of Calgary|