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

Acute Ischemic Stroke Clinical Trial

— ESCAPE-MeVO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05151172
• Other study ID #: Version E, November 15, 2023
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: February 2024
• Source: University of Calgary
• Contact: Karla J Ryckborst, RN
• Phone: 403 944 2863
• Email: kjryckbo[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Michael D Hill	University of Calgary

Countries where clinical trial is conducted

United States,  Canada,  Germany,  United Kingdom, 

Outcome

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