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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Covidien
Heart and Stroke Foundation of Canada
Hotchkiss Brain Institute, University of Calgary
Information provided by (Responsible Party):
Dr. Michael Hill, University of Calgary
ClinicalTrials.gov Identifier:
NCT01778335
First received: January 25, 2013
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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.

Approximately 250 people at 10-15 hospitals across Canada and other countries will participate in this study.


Condition Intervention Phase
Ischemic Stroke
Procedure: Endovascular thrombectomy/thrombolysis
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • The proportion of patients who achieve a NIHSS score of 0-2 OR a mRS score of 0-2 at 90 days. [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.



Estimated Enrollment: 250
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Endovacular mechanical thrombectomy or thrombolysis
Other Name: Endovascular mechanical thrombectomy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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 of 90 or greater. Patient must be living in their own home, apartment or seniors lodge where no nursing care is required.
  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/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 CT/CTA with target CTA to first recanalization of 90 minutes.

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 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 end of CTA acquisition (please note that if CTP is performed it should be done after CTA).
  4. No femoral pulses
  5. Very difficult endovascular access will result in a CTA to recanalization time that is longer than 90 minutes.
  6. Pregnancy; if a woman is of child-bearing potential a urine or serum beta HCG test is positive.
  7. Severe contrast allergy or absolute contraindication to iodinated contrast.
  8. Suspected intracranial dissection as a cause of stroke.
  9. Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic.
  10. 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.
  11. Patient cannot complete follow-up treatment due to co-morbid non-fatal illness.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778335

Locations
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N2T9
Sponsors and Collaborators
University of Calgary
Covidien
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
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Michael Hill, Professor, Department of Clinical Neurosciences, Hotchkiss Brain Institute, University of Calgary
ClinicalTrials.gov Identifier: NCT01778335     History of Changes
Other Study ID Numbers: Version 3.7
Study First Received: January 25, 2013
Last Updated: January 28, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
recanalization
endovascular
thrombectomy

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 28, 2014