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ACTIVE NOT RECRUITING

NCT05151172

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

Sponsor: Dr. Michael D Hill

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

530

Start Date

2022-04-15

Completion Date

2026-06-30

Last Updated

2024-08-15

Healthy Volunteers

Conditions

Acute Ischemic Stroke

Interventions

DEVICE

endovascular thrombectomy (EVT)

minimally invasive endovascular surgery for mechanical removal of occluding intracranial thrombus

OTHER

Standarad medical care

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

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

Locations (53)

Baptist Health Medical Center

Little Rock, Arkansas, United States

Sutter Health

San Francisco, California, United States

Providence Little company of Mary

Torrance, California, United States

Yale School of Medicine

New Haven, Connecticut, United States

Baptist Health Medical Centre

Jacksonville, Florida, United States

Mayo Clinic

Jacksonville, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Northwestern Medicine

Chicago, Illinois, United States

Rush university Medical Centre

Chicago, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Maryland

Baltimore, Maryland, United States

bBston Medican Center

Boston, Massachusetts, United States

Mount Sinai Health System

New York, New York, United States

The Ohio State University

Columbus, Ohio, United States

Ohio Health (Columbus ORI)

Columbus, Ohio, United States

University of Toledo

Toledo, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

University of TN Health Sciences Centre

Memphis, Tennessee, United States

Texas stroke Institute

Plano, Texas, United States

Swedish Medical Centre

Seattle, Washington, United States

University of Calgary - Foothills Medical Centre

Calgary, Alberta, Canada

University of Alberta Hospital

Edmonton, Alberta, Canada

Vancouver general hospital

Vancouver, British Columbia, Canada

University of Manitoba

Winnipeg, Manitoba, Canada

Queen Elizabeth II HSC

Halifax, Nova Scotia, Canada

Health Sciences North

Greater Sudbury, Ontario, Canada

Hamilton Health sciences

Hamilton, Ontario, Canada

London Health Sciences

London, Ontario, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

St Michael's hospital

Toronto, Ontario, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

Montreal Neurological Institute

Montreal, Quebec, Canada

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Klinikum Altenburger Lang

Altenburg, Germany

Albert-Ludwigs-Universität Freiburg

Freiberg, Germany

University of Heidelberg

Heidelberg, Germany

University Hospital Tübingen

Tübingen, Germany

University Hospital of Bonn

Venusberg, Germany

Wurzberg University Hospital

Würzburg, Germany

Royal Stoke University Hospital

Stoke-on-Trent, Staffordshire, United Kingdom

Royal Victoria Hospital

Belfast, United Kingdom

Cambridge University Hospital

Cambridge, United Kingdom

Hull University Teaching Hospital

Hull, United Kingdom

Leeds Teaching Hospitals

Leeds, United Kingdom

The Royal London Hospital

London, United Kingdom

Kings college Hospital

London, United Kingdom

St Georges Hospital

London, United Kingdom

Charing Cross Hospital

London, United Kingdom

University College London Hospital

London, United Kingdom

Nottingham University Hospital

Nottingham, United Kingdom

John Radcliffe Hopital

Oxford, United Kingdom

University Hospital Southhampton

Southampton, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (53)