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Acute Ischemic StrokeESCAPE-MeVONCT05151172

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

A study testing endovascular thrombectomy (EVT) and Standarad medical care in people with Acute Ischemic Stroke, run by Dr. Michael D Hill at 53 sites in 4 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
endovascular thrombectomy (EVT) and Standarad medical care
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
530 participants
Where
53 sitesin 4 countries
Study dates
15 Apr 2022to 30 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Acute ischemic stroke clinically eligible for immediate EVT
  • Age ≥18 years at the date of randomization
  • Time from onset (or last-seen-well) to randomization <12 hours
  • Disabling stroke defined as follows:
  • baseline National Institutes of Health Stroke Scale (NIHSS) score >5 at the time of randomization
  • 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
Show all 9Show fewer
  • 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.
  • . Clinical deficit commensurate with MeVO occlusion location
  • . Signed informed consent, two-physician consent, or deferral of consent where approved

Who cannot join

  • ASPECTS ≤ 5
  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

53 sites in 4 countries.

53 sites in 4 countries

United States20 sites
  • University of Maryland

    Baltimore, Maryland, 21201

  • bBston Medican Center

    Boston, Massachusetts, 02118

  • Northwestern Medicine

    Chicago, Illinois, 60611

  • Rush university Medical Centre

    Chicago, Illinois, 60612

  • The Ohio State University

    Columbus, Ohio, 43210

  • Ohio Health (Columbus ORI)

    Columbus, Ohio, 43214

  • Baptist Health Medical Centre

    Jacksonville, Florida, 32207

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Baptist Health Medical Center

    Little Rock, Arkansas, 72205-7299

  • University of TN Health Sciences Centre

    Memphis, Tennessee, 38163

  • Yale School of Medicine

    New Haven, Connecticut, 06510

  • Mount Sinai Health System

    New York, New York, 10029

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19017

  • Texas stroke Institute

    Plano, Texas, 75075

  • Sutter Health

    San Francisco, California, 94109

  • Swedish Medical Centre

    Seattle, Washington, 98122

  • Tampa General Hospital

    Tampa, Florida, 33606

  • University of Toledo

    Toledo, Ohio, 43606

  • Providence Little company of Mary

    Torrance, California, 90503

Other trials in United States

Canada14 sites
  • University of Calgary - Foothills Medical Centre

    Calgary, Alberta, T2N2T9

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1

  • Queen Elizabeth II HSC

    Halifax, Nova Scotia, B3H 3A7

  • Hamilton Health sciences

    Hamilton, Ontario, L8L2X2

  • London Health Sciences

    London, Ontario, N6A 5A5

  • Montreal Neurological Institute

    Montreal, Quebec, H3A 2B4

  • Ottawa Hospital Research Institute

    Ottawa, Ontario

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • St Michael's hospital

    Toronto, Ontario, M5C 1R6

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • Vancouver general hospital

    Vancouver, British Columbia, V5Z 1M9

  • University of Manitoba

    Winnipeg, Manitoba, RE3 3P5

Other trials in Canada

United Kingdom13 sites
  • Royal Victoria Hospital

    Belfast, BT12 6BA

  • Cambridge University Hospital

    Cambridge, CB2 0QQ

  • Hull University Teaching Hospital

    Hull, HU3 2JZ

  • Leeds Teaching Hospitals

    Leeds, LS1 3EX

  • The Royal London Hospital

    London, E1 !FR

  • Kings college Hospital

    London, SE5 9RS

  • St Georges Hospital

    London, SW17 0QT

  • Charing Cross Hospital

    London, W6 8RF

  • University College London Hospital

    London

  • Nottingham University Hospital

    Nottingham, NG7 2UH

  • John Radcliffe Hopital

    Oxford, OX3 9DU

  • University Hospital Southhampton

    Southampton, SO16 6YD

  • Royal Stoke University Hospital

    Stoke-on-Trent, Staffordshire, ST4 6QG

Other trials in United Kingdom

Germany6 sites
  • Klinikum Altenburger Lang

    Altenburg, 04600

  • Albert-Ludwigs-Universität Freiburg

    Freiberg, 79106

  • University of Heidelberg

    Heidelberg

  • University Hospital Tübingen

    Tübingen, 72076

  • University Hospital of Bonn

    Venusberg, 53127

  • Wurzberg University Hospital

    Würzburg, 97090

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
endovascular thrombectomy (EVT), Standarad medical care
Keywords
endovascular thrombectomy
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • endovascular thrombectomy (EVT)Device

    Also called solitaire X

    minimally invasive endovascular surgery for mechanical removal of occluding intracranial thrombus

  • Standarad medical careOther

    Stanadard medical care wil involve use of thrombolytic drugs, Blood pressure management, use of antiplatelet or anti coagulant drugs

Study groups in NCT05151172
Study groupRoleWhat they receive
best medical carePlacebo comparatorAll 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.
Receives: Other: Standarad medical care
endovascular thrombectomyExperimentalAll 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.
Receives: Device: endovascular thrombectomy (EVT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. modified Rankin Scale score (mRS)

    global neurological functional outcome measured on the modified Rankin Scale

    Measured: 90 days after randomization

Secondary outcomes (3)
  1. National Institutes of Health Stroke Scale (NIHSS)

    Stroke scale

    Measured: 24 Hour

  2. Mortality

    All cause mortality

    Measured: 90 days

  3. European Quality of LIfe Scale (EQ-5D-5L)

    Self reported health status

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2021
  2. Study start15 Apr 2022
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
ESCAPE-MeVO is a multicenter, prospective, randomized, open- label study with blinded endpoint evaluation (PROBE design). Subjects will be allocated (1:1) to best guideline-based best medical care plus endovascular therapy (EVT) vs. best guideline- based best medical care alone.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
530 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05151172
Sponsor's protocol ID
Version E, November 15, 2023
Acronym
ESCAPE-MeVO
Status last verified
Aug 2024
First submitted
25 Nov 2021
Last updated
15 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: We plan to share IPD in due course after the study is completed and published.

Publications

  • Pensato U, Jindal G, Diprose W, Ganesh A, Charatpangoon P, MacDonald E, Stebner A, Bosshart S, Dowlatshahi D, Volders D, Kennedy J, Mohlenbruch M, Buck BH, Nimjee S, Booth T, Jumaa M, Shankar JJ, Dorn F, Demchuk AM, Goyal M, Hill MD, Ospel JM; ESCAPE-MEVO Investigators. Thrombectomy for Acute Stroke Due to Medium Vessel Occlusion Across Perfusion Mismatch Profiles: A Post Hoc Analysis of the ESCAPE-MeVO Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2638823. doi: 10.1001/jamanetworkopen.2026.38823.

    PubMed 42867860
  • Goyal M, Ospel JM, Ganesh A, Dowlatshahi D, Volders D, Mohlenbruch MA, Jumaa MA, Nimjee SM, Booth TC, Buck BH, Kennedy J, Shankar JJ, Dorn F, Zhang L, Hametner C, Nardai S, Zafar A, Diprose W, Vatanpour S, Stebner A, Bosshart S, Singh N, Sebastian I, Uchida K, Ryckborst KJ, Fahed R, Hu SX, Vollherbst DF, Zaidi SF, Lee VH, Lynch J, Rempel JL, Teal R, Trivedi A, Bode FJ, Ogungbemi A, Pham M, Orosz P, Abdalkader M, Taschner C, Tarpley J, Poli S, Singh RJ, De Leacy R, Lopez G, Sahlas D, Chen M, Burns P, Schaafsma JD, Marigold R, Reich A, Amole A, Field TS, Swartz RH, Settecase F, Lenzser G, Ortega-Gutierrez S, Asdaghi N, Lobotesis K, Siddiqui AH, Berrouschot J, Mokin M, Ebersole K, Schneider H, Yoo AJ, Mandzia J, Klostranec J, Jadun C, Patankar T, Sauvageau E, Lenthall R, Peeling L, Huynh T, Budzik R, Lee SK, Makalanda L, Levitt MR, Perry RJ, Hlaing T, Jahromi BS, Singh P, Demchuk AM, Hill MD; ESCAPE-MeVO Investigators. Endovascular Treatment of Stroke Due to Medium-Vessel Occlusion. N Engl J Med. 2025 Apr 10;392(14):1385-1395. doi: 10.1056/NEJMoa2411668. Epub 2025 Feb 5.

    PubMed 39908448
  • Ospel JM, Dowlatshahi D, Demchuk A, Volders D, Mohlenbruch M, Nimjee S, Kennedy J, Buck B, Shankar JJ, Booth TC, Jumaa MA, Fahed R, Ganesh A, Zhang Q, Doram C, Ryckborst KJ, Hill MD, Goyal M; ESCAPE-MeVO investigators. Endovascular treatment to improve outcomes for medium vessel occlusions: The ESCAPE-MeVO trial. Int J Stroke. 2024 Oct;19(9):1064-1070. doi: 10.1177/17474930241262642. Epub 2024 Jun 20.

    PubMed 38845180

Questions about this trial

What is this clinical trial studying?

A study testing endovascular thrombectomy (EVT) and Standarad medical care in people with Acute Ischemic Stroke, run by Dr. Michael D Hill at 53 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Canada, United Kingdom, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

modified Rankin Scale score (mRS) (time frame: 90 days after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05151172, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.

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