EndovaSCular TreAtment to imProve outcomEs for Medium Vessel Occlusions (ESCAPE-MeVO Trial)

Last updated: August 14, 2024
Sponsor: Dr. Michael D Hill
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Stroke

Cardiac Ischemia

Thrombosis

Treatment

endovascular thrombectomy (EVT)

Standarad medical care

Clinical Study ID

NCT05151172
Version E, November 15, 2023
  • Ages > 18
  • All Genders

Study Summary

Stroke occurs when a blood clot causes a blockage in a blood vessel (artery) within the brain. This type of stroke is called an ischemic stroke and carries a high risk of disability or death. Stroke must be treated very fast. Any delay of even 10 minutes can result in the difference between an independent and a disabled outcome, and in some cases between life and death. Endovascular therapy (EVT) or Thrombectomy is a procedure to remove the blood clot (thrombus) from a blood vessel to reopen it (recanalization). Patients are likely to benefit from a thrombectomy procedure when it is performed in a larger blood vessel. Currently it is not known if thrombectomy procedure will benefit the patients presenting with the stroke that has been caused by a blood clot in a medium sized blood vessel (medium vessel occlusion, MeVO). This trial will enrol patients diagnosed with acute stroke due to a clot in the medium sized vessel. The patients will be randomized within 12 hours of their symptom onset to either standard of care or standard of care plus thrombectomy procedure. The participation will last for 12 months Escape MeVO coordinating centre is located at the University of Calgary. There will be up to 75 sites. We will be recruiting a total of 530 patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Acute ischemic stroke clinically eligible for immediate EVT

  2. Age ≥18 years at the date of randomization

  3. Time from onset (or last-seen-well) to randomization <12 hours

  4. Disabling stroke defined as follows:

  5. baseline National Institutes of Health Stroke Scale (NIHSS) score >5 at thetime of randomization

  6. NIHSS 3-5 with disabling deficit (eg. hemianopia, aphasia, loss of handfunction) as determined by the attending physician in context of the patient'slife situation

  7. Confirmed symptomatic and endovascularly treatable MeVO based on neurovascularnon-invasive imaging (mCTA or MRA), at one or more of the following locations: M2 orM3 segment, A2 or A3 segment, P2 or P3 segment1.

  8. . Clinical deficit commensurate with MeVO occlusion location

  9. . Signed informed consent, two-physician consent, or deferral of consent whereapproved

Exclusion

Exclusion Criteria:

  1. ASPECTS ≤ 5

  2. The following depend on the imaging modality of the participating site:

9a. NCCT + mCTA

  • Well demarcated hypodensity in the majority of the brain parenchyma supplied by theoccluded vessel or absence of collaterals in the affected territory on the delayedphases of the mCTA OR 9b. NCCT + (m)CTA + CTP**

  • Lack of core: penumbra mismatch (if the CTP is uninterpretable, e.g., due to motionartifacts, apply exclusion criteria from 9a. If single-phase CTA is performed, scorecollaterals accordingly. If NCCT + mCTA + CTP are all performed, the core: penumbramismatch criteria are sufficient for exclusion) OR 9c. MRI

  • Diffusion restriction in the majority of the brain parenchyma supplied by theoccluded vessel

  • if MR perfusion is performed: lack of core:penumbra mismatch 10) Any evidence ofintracranial hemorrhage on qualifying imaging 11) Patients living in a nursing homeor requiring daily nursing care or assistance with activities of daily living.

  1. Patient has a major co-morbid illness, such as severe dementia, advancedcancer, advanced heart failure etc. such that they are unlikely to be able tocomplete follow-up or they are unlikely to achieve the primary outcome due tothe underlying illness (rather than the stroke or its treatment).

  2. Pregnancy: female with positive urine or serum beta human chorionicgonadotropin (β-hCG) test 14) Participation in another clinical therapeuticintervention trial

Study Design

Total Participants: 530
Treatment Group(s): 2
Primary Treatment: endovascular thrombectomy (EVT)
Phase:
Study Start date:
April 15, 2022
Estimated Completion Date:
June 30, 2026

Study Description

ESCAPE-MeVO is a multicenter, prospective, randomized, open- label study with blinded endpoint evaluation (PROBE design). Participants will be randomized to routine best medical stroke care governed by current guidelines (control group) or to EVT plus best medical care. EVT will be performed with one of the Solitaire group of intracranial stent-retriever devices (Solitaire X, Medtronic) as the first line approach according to the manufacturers' specifications for use.

Patients with clinical symptoms of acute stroke, last seen normal within the last 12 hours, and with either NIHSS ≥ 5 or NIHSS 3-5 due to disabling symptoms in the judgement of the stroke team shall undergo imaging to identify the MeVO and assess the status of the affected brain parenchyma. As is being currently practiced across different stroke centers, imaging may follow different imaging paradigms:

  • Option 1: NCCT + mCTA (first phase covers intracranial and extracranial vessels)

  • Option 2: NCCT + mCTA/spCTA + either mCTA tissue level perfusion maps or CTP perfusion maps

  • Option 3: DWI-MRI + MRA (of both the intracranial and extracranial vessels). Approach to the EVT procedure and technique will be at the discretion of the interventionist and team, with the exception that the first thrombectomy attempt is performed with one of the Solitaire group of intracranial stent-retriever devices (Solitaire X, Medtronic). Available, approved off-the-shelf, secondary devices may be used if reperfusion success is not achieved after use of the first device, at the discretion of the neuro-interventionalist

This study consists of one 90-day study period for each participant. Participants will be hospitalized for care after their acute stroke according to the current standard of care. Participants are required to return to clinic on Day 90 for end-of-study assessment.

Connect with a study center

  • University of Calgary - Foothills Medical Centre

    Calgary, Alberta T2N2T9
    Canada

    Site Not Available

  • University of Alberta Hospital

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • Vancouver general hospital

    Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

  • University of Manitoba

    Winnipeg, Manitoba RE3 3P5
    Canada

    Site Not Available

  • University of Mannitoba

    Winnipeg, Mannitoba RE3 3P5
    Canada

    Active - Recruiting

  • Queen Elizabeth II HSC

    Halifax, Nova Scotia B3H 3A7
    Canada

    Site Not Available

  • Hamilton Health sciences

    Hamilton, Ontario L8L2X2
    Canada

    Site Not Available

  • London Health Sciences

    London, Ontario N6A 5A5
    Canada

    Site Not Available

  • Ottawa Hospital Research Institute

    Ottawa, Ontario
    Canada

    Site Not Available

  • Health Sciences North

    Sudbury, Ontario P3E 5J1
    Canada

    Site Not Available

  • St Michael's hospital

    Toronto, Ontario M5C 1R6
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Toronto Western Hospital

    Toronto, Ontario M5T 2S8
    Canada

    Site Not Available

  • Montreal Neurological Institute

    Montréal, Quebec H3A 2B4
    Canada

    Site Not Available

  • Royal University Hospital

    Saskatoon, Saskatchewan S7N 0W8
    Canada

    Site Not Available

  • Klinikum Altenburger Lang

    Altenburg, 04600
    Germany

    Site Not Available

  • Albert-Ludwigs-Universität Freiburg

    Freiberg, 79106
    Germany

    Site Not Available

  • University of Heidelberg

    Heidelberg,
    Germany

    Site Not Available

  • University Hospital Tübingen

    Tubingen, 72076
    Germany

    Site Not Available

  • University Hospital of Bonn

    Venusberg, 53127
    Germany

    Site Not Available

  • Wurzberg University Hospital

    Würzburg, 97090
    Germany

    Site Not Available

  • Royal Stoke University Hospital

    Stoke-on-Trent, Staffordshire ST4 6QG
    United Kingdom

    Site Not Available

  • Royal Victoria Hospital

    Belfast, BT12 6BA
    United Kingdom

    Site Not Available

  • Cambridge University Hospital

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • Hull University Teaching Hospital

    Hull, HU3 2JZ
    United Kingdom

    Site Not Available

  • Leeds Teaching Hospitals

    Leeds, LS1 3EX
    United Kingdom

    Site Not Available

  • Charing Cross Hospital

    London, W6 8RF
    United Kingdom

    Site Not Available

  • Kings college Hospital

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • St Georges Hospital

    London, SW17 0QT
    United Kingdom

    Site Not Available

  • The Royal London Hospital

    London, E1 !FR
    United Kingdom

    Site Not Available

  • University College London Hospital

    London,
    United Kingdom

    Site Not Available

  • Nottingham University Hospital

    Nottingham, NG7 2UH
    United Kingdom

    Site Not Available

  • John Radcliffe Hopital

    Oxford, OX3 9DU
    United Kingdom

    Site Not Available

  • University Hospital Southhampton

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Baptist Health Medical Center

    Little Rock, Arkansas 72205-7299
    United States

    Site Not Available

  • Sutter Health

    San Francisco, California 94109
    United States

    Site Not Available

  • Providence Little company of Mary

    Torrance, California 90503
    United States

    Site Not Available

  • Yale School of Medicine

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Baptist Health Medical Centre

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Mayo Clinic

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Site Not Available

  • Northwestern Medicine

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Rush university Medical Centre

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • bBston Medican Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • boston Medican Center

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

  • Mount Sinai Health System

    New York, New York 10029
    United States

    Site Not Available

  • Ohio Health (Columbus ORI)

    Columbus, Ohio 43214
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • University of Toledo

    Toledo, Ohio 43606
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19017
    United States

    Site Not Available

  • University of TN Health Sciences Centre

    Memphis, Tennessee 38163
    United States

    Site Not Available

  • Texas stroke Institute

    Plano, Texas 75075
    United States

    Site Not Available

  • Swedish Medical Centre

    Seattle, Washington 98122
    United States

    Site Not Available

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