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

NCT05151172 | Active Not Recruiting DMC FDA Device

• 1 other identifier: Version E, November 15, 2023
• Study Type: interventional
• Target: 530
• Locations: 4 countries
• Sites: 53

Brief 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.

Conditions

Acute Ischemic Stroke

Keywords

endovascular thrombectomy

Outcome Measures

Primary Outcomes (1)

• modified Rankin Scale score (mRS)

  global neurological functional outcome measured on the modified Rankin Scale

  90 days after randomization

Secondary Outcomes (3)

• National Institutes of Health Stroke Scale (NIHSS)

  24 Hour

• Mortality

  90 days

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

  90 days

Study Arms (2)

best medical care

PLACEBO COMPARATOR

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

endovascular thrombectomy

EXPERIMENTAL

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)

Interventions

endovascular thrombectomy (EVT) DEVICE

minimally invasive endovascular surgery for mechanical removal of occluding intracranial thrombus

Also known as: solitaire X

endovascular thrombectomy

Standarad medical care OTHER

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

best medical care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• ASPECTS ≤ 5
• The following depend on the imaging modality of the participating site:
• a. 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\*\*
• 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.
• \) 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).
• \) Pregnancy: female with positive urine or serum beta human chorionic gonadotropin (β-hCG) test 14) Participation in another clinical therapeutic intervention trial

Sponsors & Collaborators

• Dr. Michael D Hill: lead
• University of Calgary: collaborator

Study Sites (53)

Baptist Health Medical Center

Little Rock, Arkansas, 72205-7299, United States

Location

Sutter Health

San Francisco, California, 94109, United States

Location

Providence Little company of Mary

Torrance, California, 90503, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

Baptist Health Medical Centre

Jacksonville, Florida, 32207, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

Rush university Medical Centre

Chicago, Illinois, 60612, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

bBston Medican Center

Boston, Massachusetts, 02118, United States

Location

Mount Sinai Health System

New York, New York, 10029, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Ohio Health (Columbus ORI)

Columbus, Ohio, 43214, United States

Location

University of Toledo

Toledo, Ohio, 43606, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19017, United States

Location

University of TN Health Sciences Centre

Memphis, Tennessee, 38163, United States

Location

Texas stroke Institute

Plano, Texas, 75075, United States

Location

Swedish Medical Centre

Seattle, Washington, 98122, United States

Location

University of Calgary - Foothills Medical Centre

Calgary, Alberta, T2N2T9, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Vancouver general hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

University of Manitoba

Winnipeg, Manitoba, RE3 3P5, Canada

Location

Queen Elizabeth II HSC

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Health Sciences North

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Hamilton Health sciences

Hamilton, Ontario, L8L2X2, Canada

Location

London Health Sciences

London, Ontario, N6A 5A5, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St Michael's hospital

Toronto, Ontario, M5C 1R6, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Montreal Neurological Institute

Montreal, Quebec, H3A 2B4, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Klinikum Altenburger Lang

Altenburg, 04600, Germany

Location

Albert-Ludwigs-Universität Freiburg

Freiberg, 79106, Germany

Location

University of Heidelberg

Heidelberg, Germany

Location

University Hospital Tübingen

Tübingen, 72076, Germany

Location

University Hospital of Bonn

Venusberg, 53127, Germany

Location

Wurzberg University Hospital

Würzburg, 97090, Germany

Location

Royal Stoke University Hospital

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

Location

Royal Victoria Hospital

Belfast, BT12 6BA, United Kingdom

Location

Cambridge University Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Hull University Teaching Hospital

Hull, HU3 2JZ, United Kingdom

Location

Leeds Teaching Hospitals

Leeds, LS1 3EX, United Kingdom

Location

The Royal London Hospital

London, E1 !FR, United Kingdom

Location

Kings college Hospital

London, SE5 9RS, United Kingdom

Location

St Georges Hospital

London, SW17 0QT, United Kingdom

Location

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

University College London Hospital

London, United Kingdom

Location

Nottingham University Hospital

Nottingham, NG7 2UH, United Kingdom

Location

John Radcliffe Hopital

Oxford, OX3 9DU, United Kingdom

Location

University Hospital Southhampton

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 39908448 DERIVED

• 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.

  PMID: 38845180 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mayank Goyal, MD

  University of Calgary and Foothills Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 9, 2021
• Study Start: April 15, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 36 months after study completion.
• Access Criteria: We will attempt to post the data in a public data archive.

Locations

CA (14); GB (13); DE (6); US (20)