Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE)

March 20, 2015 updated by: Dr. Michael Hill, University of Calgary

Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times (ESCAPE) Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

316

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N2T9
        • University of Calgary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria A. Clinical (Heterogeneous sampling frame)

  1. Acute ischemic stroke
  2. Age 18 or greater
  3. Onset (last-seen-well) time to randomization time < 12 hours.
  4. Disabling stroke defined as a baseline NIHSS > 5 at the time of randomization.

  5. Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Barthel Index > 90. Patient must be living in their own home, apartment or seniors lodge where no nursing care is required.

    B. Imaging (Homogeneous target population)

  6. 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.
  7. Non-contrast CT and CTA for trial eligibility performed or repeated at ESCAPE stroke center with endovascular suite on-site.
  8. Endovascular treatment intended to be initiated (groin puncture) within 60 minutes of baseline non-contrast CT with target baseline non-contrast CT to first recanalization of 90 minutes.
  9. Signed informed consent or appropriate signed deferral of consent where approved.

Exclusion Criteria

  1. Baseline non-contrast CT reveals a moderate/large core defined as extensive early ischemic changes of ASPECTS 0-5 in the territory of symptomatic intracranial occlusion.

  2. Other confirmation of a moderate to large core defined one of three ways:

    1. On a single phase, multiphase or dynamic CTA: no or minimal collaterals in a region greater than 50% of the MCA territory when compared to pial filling on the contralateral side (multiphase/dynamic CTA preferred) OR
    2. On CT perfusion (>8 cm coverage): a low CBV and very low CBF ASPECTS <6 AND in the symptomatic MCA territory OR
    3. On CT perfusion(<8 cm coverage): a region of low CBV and very low CBF >1/3 of the CTP imaged symptomatic MCA territory.
  3. Groin puncture is not possible within 60 minutes of the first slice of non-contrast CT acquisition (please note that if CTP is performed it should be done after CTA).
  4. No femoral pulses or very difficult endovascular access that will result in a non-contrast CT-to-recanalization time that is longer than 90 minutes, or will result in an inability to deliver endovascular therapy.
  5. Pregnancy; if a woman is of child-bearing potential a urine or serum beta HCG test is positive.
  6. Severe contrast allergy or absolute contraindication to iodinated contrast.
  7. Suspected intracranial dissection as a cause of stroke.
  8. Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic.
  9. Patient has a severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Endovascular mechanical thrombectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Shift in the mRS score, defined by a proportional odds model.
Time Frame: 90 days
90 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients who suffer a Safety Outcome
Time Frame: 0-90 days
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.
0-90 days
Economic (cost-effectiveness) analysis
Time Frame: 90 days
Economic analysis
90 days
Evaluation of waiver/deferral of consent process
Time Frame: 90 days
Qualitative evaluation of the waiver/deferral of consent process
90 days
Safety - Other
Time Frame: 90 days

(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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

Medtronic - MITG
Heart and Stroke Foundation of Canada
Hotchkiss Brain Institute, University of Calgary

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

January 25, 2013

First Submitted That Met QC Criteria

January 28, 2013

First Posted (Estimate)

January 29, 2013

Study Record Updates

Last Update Posted (Estimate)

March 23, 2015

Last Update Submitted That Met QC Criteria

March 20, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version 3.8

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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