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

A Multicentre, Prospective, Randomized, Parallel Group, Open-label Design to Determine the Efficacy and Safety of Endovascular Thrombectomy for Ischemic Stroke Patients With Symptomatic Acute Medium Vessel Intracranial Occlusions

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Other: Standarad medical care; Device: endovascular thrombectomy (EVT)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 530
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N2T9
      • University of Calgary - Foothills Medical Centre
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada, RE3 3P5
      • University of Manitoba
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Queen Elizabeth II HSC
  • Ontario
    • Hamilton, Ontario, Canada, L8L2X2
      • Hamilton Health Sciences
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences
    • Ottawa, Ontario, Canada
      • Ottawa Hospital Research Institute
    • Sudbury, Ontario, Canada, P3E 5J1
      • Health Sciences North
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital
    • Toronto, Ontario, Canada, M5C 1R6
      • St Michael's Hospital
  • Quebec
    • Montréal, Quebec, Canada, H3A 2B4
      • Montreal Neurological Institute
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital
• Germany
  • Altenburg, Germany, 04600
    • Klinikum Altenburger Lang
  • Freiberg, Germany, 79106
    • Albert-Ludwigs-Universität Freiburg
  • Heidelberg, Germany
    • University of Heidelberg
  • Tubingen, Germany, 72076
    • University Hospital Tübingen
  • Venusberg, Germany, 53127
    • University Hospital of Bonn
  • Würzburg, Germany, 97090
    • Wurzberg University Hospital
• United Kingdom
  • Belfast, United Kingdom, BT12 6BA
    • Royal Victoria Hospital
  • Cambridge, United Kingdom, CB2 0QQ
    • Cambridge University Hospital
  • Hull, United Kingdom, HU3 2JZ
    • Hull University Teaching Hospital
  • Leeds, United Kingdom, LS1 3EX
    • Leeds Teaching Hospitals
  • London, United Kingdom, W6 8RF
    • Charing Cross Hospital
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital
  • London, United Kingdom
    • University College London Hospital
  • London, United Kingdom, SW17 0QT
    • St Georges Hospital
  • London, United Kingdom, E1 !FR
    • The Royal London Hospital
  • Nottingham, United Kingdom, NG7 2UH
    • Nottingham University Hospital
  • Oxford, United Kingdom, OX3 9DU
    • John Radcliffe Hopital
  • Southampton, United Kingdom, SO16 6YD
    • University Hospital Southhampton
  • Staffordshire
    • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
      • Royal Stoke University Hospital
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205-7299
      • Baptist Health Medical Center
  • California
    • San Francisco, California, United States, 94109
      • Sutter Health
    • Torrance, California, United States, 90503
      • Providence Little Company of Mary
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale School of Medicine
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
    • Jacksonville, Florida, United States, 32207
      • Baptist Health Medical Centre
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medicine
    • Chicago, Illinois, United States, 60612
      • Rush university Medical Centre
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • bBston Medican Center
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Health System
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
    • Columbus, Ohio, United States, 43214
      • Ohio Health (Columbus ORI)
    • Toledo, Ohio, United States, 43606
      • University of Toledo
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19017
      • Thomas Jefferson University
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • University of TN Health Sciences Centre
  • Texas
    • Plano, Texas, United States, 75075
      • Texas Stroke Institute
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

   1. baseline National Institutes of Health Stroke Scale (NIHSS) score >5 at the time of randomization
   2. NIHSS 3-5 with disabling deficit (eg. hemianopia, aphasia, loss of hand function) as determined by the attending physician in context of the patient's life situation
5. Confirmed symptomatic and endovascularly treatable MeVO based on neurovascular non-invasive imaging (mCTA or MRA), at one or more of the following locations: M2 or M3 segment, A2 or A3 segment, P2 or P3 segment1.
6. . Clinical deficit commensurate with MeVO occlusion location

7. . Signed informed consent, two-physician consent, or deferral of consent where approved

   Exclusion Criteria:

8. ASPECTS ≤ 5
9. 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 the occluded vessel or absence of collaterals in the affected territory on the delayed phases of the mCTA OR 9b. NCCT + (m)CTA + CTP**
• Lack of core: penumbra mismatch (if the CTP is uninterpretable, e.g., due to motion artifacts, apply exclusion criteria from 9a. If single-phase CTA is performed, score collaterals accordingly. If NCCT + mCTA + CTP are all performed, the core: penumbra mismatch criteria are sufficient for exclusion) OR 9c. MRI
• Diffusion restriction in the majority of the brain parenchyma supplied by the occluded vessel

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

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

  13) Pregnancy: female with positive urine or serum beta human chorionic gonadotropin (β-hCG) test 14) Participation in another clinical therapeutic intervention trial

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: best medical care; All patients will receive the best standard of medical care according to modern acute stroke care guidelines All patients including the ones in control arm will receive the best standard of medical care according to modern acute stroke care guidelines. The model will be the Canadian best practices guidelines for acute stroke care. These are very similar to the guidelines of the American Stroke Association and the European Stroke Organization. All participants are expected to be admitted to hospital as part of routine standard of care.It is expected that all participants will undergo a routine work-up for the mechanism of their stroke and be treated appropriately and definitively.	Other: Standarad medical care; Stanadard medical care wil involve use of thrombolytic drugs, Blood pressure management, use of antiplatelet or anti coagulant drugs
Experimental: endovascular thrombectomy; All participants will receive the best standard of medical care according to modern acute stroke care guidelines. In the intervention/experimental arm, participants will be treated with endovascular thrombectomy with a Solitaire device (Medtronic) as the first line approach. The trial mandates that the first attempt is performed with a Solitaire X device (3mm, 4mm or 6mm diameter devices; Medtronic). The remaining treatment technique is left to the discretion of the treating neurointerventionalist. Secondary devices may be used if success is not achieved after use of the first device.	Device: endovascular thrombectomy (EVT); minimally invasive endovascular surgery for mechanical removal of occluding intracranial thrombus; Other Names: solitaire X

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
modified Rankin Scale score (mRS)	global neurological functional outcome measured on the modified Rankin Scale	90 days after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Institutes of Health Stroke Scale (NIHSS)	Stroke scale	24 Hour
Mortality	All cause mortality	90 days
European Quality of LIfe Scale (EQ-5D-5L)	Self reported health status	90 days

Collaborators and Investigators

• Sponsor: Dr. Michael D Hill
• Collaborators: University of Calgary
• Investigators: Principal Investigator: Mayank Goyal, MD, University of Calgary and Foothills Medical Centre

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 25, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: endovascular thrombectomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: Version E, November 15, 2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to share IPD in due course after the study is completed and published.
• IPD Sharing Time Frame: 36 months after study completion.
• IPD Sharing Access Criteria: We will attempt to post the data in a public data archive.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes