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

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ClinicalTrials.gov Identifier: NCT05151172
Recruitment Status : Recruiting
First Posted : December 9, 2021
Last Update Posted : February 8, 2024
Sponsor:
Collaborator:
University of Calgary
Information provided by (Responsible Party):
Dr. Michael D Hill, University of Calgary

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.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Device: endovascular thrombectomy (EVT) Other: Standarad medical care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 530 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 15, 2022
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arm Intervention/treatment
Placebo Comparator: 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.
Other: Standarad medical care
Stanadard medical care wil involve use of thrombolytic drugs, Blood pressure management, use of antiplatelet or anti coagulant drugs

Experimental: 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.
Device: endovascular thrombectomy (EVT)
minimally invasive endovascular surgery for mechanical removal of occluding intracranial thrombus
Other Name: solitaire X




Primary Outcome Measures :
  1. modified Rankin Scale score (mRS) [ Time Frame: 90 days after randomization ]
    global neurological functional outcome measured on the modified Rankin Scale


Secondary Outcome Measures :
  1. National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: 24 Hour ]
    Stroke scale

  2. Mortality [ Time Frame: 90 days ]
    All cause mortality

  3. European Quality of LIfe Scale (EQ-5D-5L) [ Time Frame: 90 days ]
    Self reported health status



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05151172


Contacts
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Contact: Karla J Ryckborst, RN 403 944 2863 kjryckbo@ucalgary.ca
Contact: Qiao Zhang, MSc qiao.zhang@ucalgary.ca

Locations
Show Show 53 study locations
Sponsors and Collaborators
Dr. Michael D Hill
University of Calgary
Investigators
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Principal Investigator: Mayank Goyal, MD University of Calgary and Foothills Medical Centre
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Responsible Party: Dr. Michael D Hill, Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT05151172    
Other Study ID Numbers: Version E, November 15, 2023
First Posted: December 9, 2021    Key Record Dates
Last Update Posted: February 8, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We plan to share IPD in due course after the study is completed and published.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 36 months after study completion.
Access Criteria: We will attempt to post the data in a public data archive.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Dr. Michael D Hill, University of Calgary:
endovascular thrombectomy
Additional relevant MeSH terms:
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Ischemic Stroke
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases