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

NCT ID: NCT05151172

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 530 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-15
• Study Completion Date: 2026-06-30

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

best medical care

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.

Group Type: PLACEBO_COMPARATOR

Standarad medical care

Intervention Type: OTHER

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

endovascular thrombectomy

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.

Group Type: EXPERIMENTAL

endovascular thrombectomy (EVT)

Intervention Type: DEVICE

minimally invasive endovascular surgery for mechanical removal of occluding intracranial thrombus

Interventions

endovascular thrombectomy (EVT)

minimally invasive endovascular surgery for mechanical removal of occluding intracranial thrombus

Intervention Type: DEVICE

Standarad medical care

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

Intervention Type: OTHER

Other Intervention Names

solitaire X

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**
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: collaborator

Dr. Michael D Hill

OTHER

Sponsor Role: lead

Responsible Party

Dr. Michael D Hill

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mayank Goyal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary and Foothills Medical Centre

Locations

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

Countries

United States; Canada; Germany; United Kingdom

References

Goyal M, Ospel JM, Ganesh A, Dowlatshahi D, Volders D, Mohlenbruch MA, Jumaa MA, Nimjee SM, Booth TC, Buck BH, Kennedy J, Shankar JJ, Dorn F, Zhang L, Hametner C, Nardai S, Zafar A, Diprose W, Vatanpour S, Stebner A, Bosshart S, Singh N, Sebastian I, Uchida K, Ryckborst KJ, Fahed R, Hu SX, Vollherbst DF, Zaidi SF, Lee VH, Lynch J, Rempel JL, Teal R, Trivedi A, Bode FJ, Ogungbemi A, Pham M, Orosz P, Abdalkader M, Taschner C, Tarpley J, Poli S, Singh RJ, De Leacy R, Lopez G, Sahlas D, Chen M, Burns P, Schaafsma JD, Marigold R, Reich A, Amole A, Field TS, Swartz RH, Settecase F, Lenzser G, Ortega-Gutierrez S, Asdaghi N, Lobotesis K, Siddiqui AH, Berrouschot J, Mokin M, Ebersole K, Schneider H, Yoo AJ, Mandzia J, Klostranec J, Jadun C, Patankar T, Sauvageau E, Lenthall R, Peeling L, Huynh T, Budzik R, Lee SK, Makalanda L, Levitt MR, Perry RJ, Hlaing T, Jahromi BS, Singh P, Demchuk AM, Hill MD; ESCAPE-MeVO Investigators. Endovascular Treatment of Stroke Due to Medium-Vessel Occlusion. N Engl J Med. 2025 Apr 10;392(14):1385-1395. doi: 10.1056/NEJMoa2411668. Epub 2025 Feb 5.

Reference Type: DERIVED

PMID: 39908448 (View on PubMed)

Ospel JM, Dowlatshahi D, Demchuk A, Volders D, Mohlenbruch M, Nimjee S, Kennedy J, Buck B, Shankar JJ, Booth TC, Jumaa MA, Fahed R, Ganesh A, Zhang Q, Doram C, Ryckborst KJ, Hill MD, Goyal M; ESCAPE-MeVO investigators. Endovascular treatment to improve outcomes for medium vessel occlusions: The ESCAPE-MeVO trial. Int J Stroke. 2024 Oct;19(9):1064-1070. doi: 10.1177/17474930241262642. Epub 2024 Jun 20.

Reference Type: DERIVED

PMID: 38845180 (View on PubMed)

Other Identifiers

Version E, November 15, 2023

Identifier Type: -

Identifier Source: org_study_id