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Carotid Artery Stenting for Stroke (EASI-TOC Trial)
N/A
Recruiting
Led By Alexandre Y Poppe, MD CM
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Acute ischemic anterior circulation stroke eligible for endovascular therapy according to local guidelines, with or without prior intravenous thrombolysis
Tandem ipsilateral high-grade (≥70%) cervical internal carotid artery (ICA) stenosis or occlusion of presumed atherosclerotic etiology on initial non-invasive vascular imaging
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of endovascular procedure
Awards & highlights
EASI-TOC Trial Summary
This trial is for patients who have had a stroke and have a blockage in their neck arteries. The goal is to see if putting a stent in the neck artery improves outcomes compared to just treating the stroke.
Who is the study for?
This trial is for stroke patients with a specific blockage in the neck arteries (carotid artery disease) and an additional clot in the brain, who can get to the hospital within 24 hours of symptoms starting. They must be able to give consent and have a chance of recovery with treatment. Pregnant individuals, those unlikely to follow the study plan or attend follow-up, or with certain pre-existing conditions are excluded.Check my eligibility
What is being tested?
The EASI-TOC trial is testing if adding stenting (a procedure to keep arteries open) of the carotid artery improves recovery from stroke compared to just removing the brain clot without stenting. Participants will be randomly assigned either acute stenting plus clot removal or only clot removal.See study design
What are the potential side effects?
Possible side effects include risks associated with endovascular procedures like bleeding at puncture sites, reactions to contrast dye used during imaging, risk of further strokes due to clots dislodging, and potential complications from antiplatelet agents such as increased bleeding.
EASI-TOC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a stroke and qualify for a clot removal procedure.
Select...
I have a severe blockage in my neck artery due to plaque buildup.
Select...
I have a blockage in a major artery in my brain.
EASI-TOC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days ± 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days ± 14 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical efficacy outcome: proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2)
Secondary outcome measures
Clinical efficacy outcome: Median Modified Rankin Scale (mRS) score
Clinical efficacy outcome: Median Montreal Cognitive Assessment (MoCA) score
Clinical efficacy outcome: Median National Institutes of Health Stroke Scale (NIHSS) score
+7 moreOther outcome measures
: Description of type and route of administration of antiplatelet agents used peri-interventionally
: Minimum and maximum intraprocedural heart rate (beats per minute)
: Minimum and maximum systolic and diastolic intraprocedural blood pressure (mmHg)
+10 moreEASI-TOC Trial Design
2Treatment groups
Active Control
Group I: Acute StentingActive Control2 Interventions
All patients in this arm will receive standard of care with regards to intracranial thrombectomy and use of intravenous thrombolysis. In this arm, the cervical carotid artery stenosis will be revascularized with a stent during the acute thrombectomy procedure.
Group II: No Acute StentingActive Control1 Intervention
All patients in this arm will receive standard of care with regards to intracranial thrombectomy and use of intravenous thrombolysis. In this arm, the cervical carotid artery stenosis will be not revascularized with a stent during the acute thrombectomy procedure.
Find a Location
Who is running the clinical trial?
Health Sciences North Research InstituteOTHER
10 Previous Clinical Trials
1,636 Total Patients Enrolled
1 Trials studying Stroke
36 Patients Enrolled for Stroke
University of AlbertaOTHER
889 Previous Clinical Trials
384,676 Total Patients Enrolled
24 Trials studying Stroke
2,281 Patients Enrolled for Stroke
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,179 Total Patients Enrolled
3 Trials studying Stroke
787 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious problem with your nerves that affects your daily life, as determined by you or your doctor.I had a stroke and qualify for a clot removal procedure.My neck artery is not severely narrowed or blocked, as confirmed by a specific imaging test.You had a puncture in your groin within the last 24 hours.You have a pre-existing neurological condition that affects your daily life.I have a blockage in my neck artery but not in my brain.My doctor believes some of my brain tissue can be saved with a special procedure.I have a severe blockage in my neck artery due to plaque buildup.I have a blockage in the artery on the same side of my neck due to a tear.I cannot undergo certain blood vessel procedures or take blood-thinning medications.I have a blockage in a major artery in my brain.
Research Study Groups:
This trial has the following groups:- Group 1: Acute Stenting
- Group 2: No Acute Stenting
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
What is the current scope of participation in this clinical experiment?
"Affirmative. Data hosted on clinicaltrials.gov suggests that this medical trial, which was initially posted on August 31st 2020, is actively recruiting patients across 1 site with a maximum capacity of 458 participants."
Answered by AI
Are there any recruitment slots remaining for this experiment?
"Yes, the evidence on clinicaltrials.gov alludes to this study's active recruitment status, which has been in effect since August 31st 2020 and was last updated November 8th 2022."
Answered by AI
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