EndovaSCular TreAtment to imProve outcomEs for Medium Vessel Occlusions (ESCAPE-MeVO Trial) (ESCAPE-MeVO)
Acute Ischemic Stroke
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring endovascular thrombectomy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- ASPECTS < 8
- 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
Sites / Locations
- Baptist Health Medical CenterRecruiting
- Sutter HealthRecruiting
- Providence Little company of MaryRecruiting
- Yale School of MedicineRecruiting
- Baptist Health Medical CentreRecruiting
- Mayo ClinicRecruiting
- Tampa General HospitalRecruiting
- Northwestern MedicineRecruiting
- Rush university Medical CentreRecruiting
- University of MarylandRecruiting
- boston Medican CenterRecruiting
- Mount Sinai Health SystemRecruiting
- The Ohio State UniversityRecruiting
- Ohio Health (Columbus ORI)Recruiting
- Thomas Jefferson UniversityRecruiting
- Texas stroke InstituteRecruiting
- Swedish Medical CentreRecruiting
- University of Calgary - Foothills Medical CentreRecruiting
- University of Alberta HospitalRecruiting
- Vancouver general hospitalRecruiting
- University of MannitobaRecruiting
- Queen Elizabeth II HSCRecruiting
- Hamilton Health sciencesRecruiting
- London Health SciencesRecruiting
- Ottawa Hospital Research InstituteRecruiting
- Health Sciences NorthRecruiting
- Sunnybrook Health Sciences CentreRecruiting
- St Michael's hospitalRecruiting
- Toronto Western HospitalRecruiting
- Montreal Neurological InstituteRecruiting
- Royal University HospitalRecruiting
- Klinikum Altenburger LangRecruiting
- University of HeidelbergRecruiting
- University Hospital of BonnRecruiting
- Wurzberg University HospitalRecruiting
- Royal Stoke University HospitalRecruiting
- Royal Victoria HospitalRecruiting
- Cambridge University HospitalRecruiting
- Hull University Teaching HospitalRecruiting
- Leeds Teaching HospitalsRecruiting
- The Royal London HospitalRecruiting
- Kings college HospitalRecruiting
- St Georges HospitalRecruiting
- Charing Cross HospitalRecruiting
- Nottingham University HospitalRecruiting
- John Radcliffe HopitalRecruiting
- University Hospital SouthhamptonRecruiting
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
best medical care
endovascular thrombectomy
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.
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.