Acute Ischemic Stroke Clinical Trial
— ESCAPE-MeVOOfficial 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.
Status | Recruiting |
Enrollment | 530 |
Est. completion date | June 30, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 (ß-hCG) test 14) Participation in another clinical therapeutic intervention trial |
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary - Foothills Medical Centre | Calgary | Alberta |
Canada | University of Alberta Hospital | Edmonton | Alberta |
Canada | Queen Elizabeth II HSC | Halifax | Nova Scotia |
Canada | Hamilton Health sciences | Hamilton | Ontario |
Canada | London Health Sciences | London | Ontario |
Canada | Montreal Neurological Institute | Montréal | Quebec |
Canada | Ottawa Hospital Research Institute | Ottawa | Ontario |
Canada | Royal University Hospital | Saskatoon | Saskatchewan |
Canada | Health Sciences North | Sudbury | Ontario |
Canada | St Michael's hospital | Toronto | Ontario |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Canada | Toronto Western Hospital | Toronto | Ontario |
Canada | Vancouver general hospital | Vancouver | British Columbia |
Canada | University of Manitoba | Winnipeg | Manitoba |
Germany | Klinikum Altenburger Lang | Altenburg | |
Germany | Albert-Ludwigs-Universität Freiburg | Freiberg | |
Germany | University of Heidelberg | Heidelberg | |
Germany | University Hospital Tübingen | Tubingen | |
Germany | University Hospital of Bonn | Venusberg | |
Germany | Wurzberg University Hospital | Würzburg | |
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 | Charing Cross Hospital | London | |
United Kingdom | Kings college Hospital | London | |
United Kingdom | St Georges Hospital | London | |
United Kingdom | The Royal London 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 | Royal Stoke University Hospital | Stoke-on-Trent | Staffordshire |
United States | University of Maryland | Baltimore | Maryland |
United States | bBston Medican Center | Boston | Massachusetts |
United States | Northwestern Medicine | Chicago | Illinois |
United States | Rush university Medical Centre | Chicago | Illinois |
United States | Ohio Health (Columbus ORI) | Columbus | Ohio |
United States | The Ohio State University | Columbus | Ohio |
United States | Baptist Health Medical Centre | Jacksonville | Florida |
United States | Mayo Clinic | Jacksonville | Florida |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | Baptist Health Medical Center | Little Rock | Arkansas |
United States | University of TN Health Sciences Centre | Memphis | Tennessee |
United States | Yale School of Medicine | New Haven | Connecticut |
United States | Mount Sinai Health System | New York | New York |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | Texas stroke Institute | Plano | Texas |
United States | Sutter Health | San Francisco | California |
United States | Swedish Medical Centre | Seattle | Washington |
United States | Tampa General Hospital | Tampa | Florida |
United States | University of Toledo | Toledo | Ohio |
United States | Providence Little company of Mary | Torrance | California |
Lead Sponsor | Collaborator |
---|---|
Dr. Michael D Hill | University of Calgary |
United States, Canada, Germany, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | modified Rankin Scale score (mRS) | global neurological functional outcome measured on the modified Rankin Scale | 90 days after randomization | |
Secondary | National Institutes of Health Stroke Scale (NIHSS) | Stroke scale | 24 Hour | |
Secondary | Mortality | All cause mortality | 90 days | |
Secondary | European Quality of LIfe Scale (EQ-5D-5L) | Self reported health status | 90 days |
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