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Procedure
Thrombectomy for Stroke (ESCAPE-MeVO Trial)
N/A
Recruiting
Led By Mayank Goyal, MD
Research Sponsored by Dr. Michael D Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Disabling stroke defined as baseline National Institutes of Health Stroke Scale (NIHSS) score >5 at the time of randomization
Age ≥18 years at the date of randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
ESCAPE-MeVO Trial Summary
This trial will help researchers determine if a thrombectomy procedure (a medical procedure to remove a blood clot from a blood vessel) will benefit patients who have had a stroke caused by a clot in a medium sized blood vessel. The trial will enroll 530 patients who will be randomly assigned to either standard of care or standard of care plus the thrombectomy procedure. The trial will last for 12 months.
Who is the study for?
This trial is for adults over 18 who've had a stroke caused by a medium-sized blood clot in the brain, and can start treatment within 12 hours. They must have certain symptoms and imaging results that show they could benefit from EVT. People with severe other illnesses, those already in another trial, or with specific poor health indicators like low ASPECTS scores aren't eligible.Check my eligibility
What is being tested?
The ESCAPE-MeVO Trial is testing if adding endovascular thrombectomy (EVT) to standard medical care improves outcomes for patients with ischemic strokes due to medium vessel occlusions. Participants are randomly assigned to receive either just standard care or standard care plus EVT within 12 hours of symptom onset.See study design
What are the potential side effects?
While not detailed here, potential side effects of EVT may include bleeding at the puncture site, damage to blood vessels, allergic reactions to contrast dye used during imaging procedures before EVT, and risk of further stroke.
ESCAPE-MeVO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a severe stroke with an NIHSS score over 5.
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I am 18 years old or older.
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I am eligible for an emergency procedure to remove a blood clot in my brain.
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I have a confirmed MeVO that can be treated with a procedure, as shown by special brain scans.
ESCAPE-MeVO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
modified Rankin Scale score (mRS)
Secondary outcome measures
European Quality of LIfe Scale (EQ-5D-5L)
Mortality
National Institutes of Health Stroke Scale (NIHSS)
ESCAPE-MeVO Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: endovascular thrombectomyExperimental Treatment1 Intervention
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 II: best medical carePlacebo Group1 Intervention
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.
Find a Location
Who is running the clinical trial?
Dr. Michael D HillLead Sponsor
Dr. Michael HillLead Sponsor
1 Previous Clinical Trials
148 Total Patients Enrolled
University of CalgaryOTHER
792 Previous Clinical Trials
868,624 Total Patients Enrolled
34 Trials studying Stroke
40,335 Patients Enrolled for Stroke
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I live in a nursing home or need daily help with personal care.There is a clear, light area in most of the brain where the blood vessel is blocked, or there are no backup blood vessels in that part of the brain.I have symptoms matching the area of my brain affected by a blockage.I had a stroke that significantly affects my vision, speech, or hand use.You have a serious illness like severe memory loss, advanced cancer, or severe heart problems that may make it hard to finish the study or affect the main goal of the study because of the illness itself, not because of the stroke or its treatment.I have had a severe stroke with an NIHSS score over 5.Most of the brain tissue supplied by the blocked blood vessel shows restricted diffusion.There is not enough difference between the damaged and at-risk areas of the brain.I am 18 years old or older.There is any sign of bleeding inside the brain on the imaging tests.I am eligible for an emergency procedure to remove a blood clot in my brain.You are pregnant, as confirmed by a urine or blood test.I have a confirmed MeVO that can be treated with a procedure, as shown by special brain scans.Your ASPECTS score is 5 or lower.
Research Study Groups:
This trial has the following groups:- Group 1: best medical care
- Group 2: endovascular thrombectomy
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies remaining in this clinical trial?
"According to the clinicaltrials.gov website, this medical study is currently recruiting participants after being first published on April 15th 2022 and last modified on May 4th 2022."
Answered by AI
How many participants is this research endeavor accommodating?
"Affirmative. According to clinicaltrials.gov, this medical study, which started on April 15th 2022 is presently enrolling patients. Approximately 530 applicants are needed from 1 specific location."
Answered by AI
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