Clinical trial NCT05151172: EndovaSCular TreAtment to imProve outcomEs for Medium Vessel Occlusions (ESCAPE-MeVO Trial)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: endovascular thrombectomy
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: University of Calgary
First posted: 2021-12-09
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: modified Rankin Scale score (mRS)
timeFrame: 90 days after randomization
Secondary outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 24 Hour
measure: Mortality
timeFrame: 90 days
measure: European Quality of LIfe Scale (EQ-5D-5L)
timeFrame: 90 days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Baptist Health Medical Center
state: Arkansas
city: San Francisco
country: United States
facility: Sutter Health
state: California
city: Torrance
country: United States
facility: Providence Little company of Mary
state: California
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Jacksonville
country: United States
facility: Baptist Health Medical Centre
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
city: Chicago
country: United States
facility: Rush university Medical Centre
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: bBston Medican Center
state: Massachusetts
city: New York
country: United States
facility: Mount Sinai Health System
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Columbus
country: United States
facility: Ohio Health (Columbus ORI)
state: Ohio
city: Toledo
country: United States
facility: University of Toledo
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Memphis
country: United States
facility: University of TN Health Sciences Centre
state: Tennessee
city: Plano
country: United States
facility: Texas stroke Institute
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Centre
state: Washington
city: Calgary
country: Canada
facility: University of Calgary - Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver general hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II HSC
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health sciences
state: Ontario
city: London
country: Canada
facility: London Health Sciences
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
city: Sudbury
country: Canada
facility: Health Sciences North
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St Michael's hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Montréal
country: Canada
facility: Montreal Neurological Institute
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Altenburg
country: Germany
facility: Klinikum Altenburger Lang
city: Freiberg
country: Germany
facility: Albert-Ludwigs-Universität Freiburg
city: Heidelberg
country: Germany
facility: University of Heidelberg
city: Tubingen
country: Germany
facility: University Hospital Tübingen
city: Venusberg
country: Germany
facility: University Hospital of Bonn
city: Würzburg
country: Germany
facility: Wurzberg University Hospital
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke University Hospital
state: Staffordshire
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospital
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospital
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals
city: London
country: United Kingdom
facility: The Royal London Hospital
city: London
country: United Kingdom
facility: Kings college Hospital
city: London
country: United Kingdom
facility: St Georges Hospital
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: London
country: United Kingdom
facility: University College London Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hopital
city: Southampton
country: United Kingdom
facility: University Hospital Southhampton
Study officials:
affiliation: University of Calgary and Foothills Medical Centre
name: Mayank Goyal, MD
role: PRINCIPAL_INVESTIGATOR
References: