Endovascular Acute Stroke Intervention-Tandem Occlusion (EASI-TOC) study: protocol and rationale.
George N Mendes, Grégory Jacquin, Daniela Iancu...
https://pubmed.ncbi.nlm.nih.gov/42024493Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID04261478
A Multi-centre, Randomized Trial Comparing Cervical Internal Carotid Artery Stenting to No Stenting During Thrombectomy for Tandem Occlusion Stroke
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2023-11-18
458
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
C
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
M
McGill University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the best treatment for patients having an acute stroke caused by a blockage in the brain's anterior circulation combined with a severe narrowing or blockage in the neck's internal carotid artery. This condition, known as tandem occlusion or tandem lesion, affects about 15-20% of patients undergoing a procedure called endovascular thrombectomy. Current evidence is limited, so this phase III multi-center trial will compare two approaches to improve recovery after stroke. Participants will be randomly assigned to one of two groups. One group will receive standard intracranial thrombectomy along with endovascular stenting to reopen the narrowed carotid artery in the neck during the procedure. The other group will undergo thrombectomy alone without stenting. Both groups may receive intravenous thrombolysis as appropriate. The study will enroll 458 adults aged 18 and older at multiple stroke centers and follow them for up to one year. During the study, patients will be monitored for their recovery and brain function, including assessments at 90 days and one year using scales such as the Modified Rankin Scale and National Institutes of Health Stroke Scale. Researchers will also evaluate the reopening of blocked vessels, recurrence of stroke or retinal ischemia, and cognitive function. Safety and functional outcomes will be compared between the two treatment approaches to determine which provides better recovery after acute stroke with tandem occlusion.
CONDITIONS
Brief Title
Endovascular Acute Stroke Intervention - Tandem OCclusion Trial
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Acute ischemic stroke in the anterior circulation eligible for endovascular therapy
- Occlusion in the carotid terminus or segments M1 or M2 of the middle cerebral artery
- Disabling neurological deficit as judged by patient or physician
- Imaging showing salvageable brain tissue suitable for thrombectomy
- Groin puncture within 24 hours of stroke onset or last known normal
- Tandem ipsilateral high-grade (≥70%) cervical internal carotid artery stenosis or occlusion of presumed atherosclerotic origin
- Informed consent obtained from patient or surrogate or deferral allowed by ethics
You will not qualify if you...
- Pre-existing neurological impairment with modified Rankin score ≥3
- Any condition or disease making protocol adherence or 3-month follow-up unlikely
- Known contraindications to endovascular therapy, angioplasty/stenting, or antiplatelet therapy
- Tandem ipsilateral high-grade (≥70%) cervical internal carotid artery stenosis or occlusion not confirmed by angiography
- Ipsilateral carotid stenosis or occlusion caused by arterial dissection
- Isolated cervical carotid occlusion without intracranial occlusion
- Pregnancy
AI-Screening
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1
2
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Your Study Journey
Screening
Duration - Up to 24 hours from stroke onset
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single acute procedure
Participants undergo intracranial thrombectomy with or without acute carotid artery stenting during the procedure. Antiplatelet therapy is administered post-procedure according to thrombolysis status.
1 procedure visit (in-person)
Follow-up
Duration - Up to 1 year
Participants are followed up to assess functional outcomes, stroke recurrence, and safety up to one year after treatment.
Visits at approximately 24 hours, 90 days, and 1 year post-treatment
Trial Site Locations
Total: 1 location
1
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X 0C1
Actively Recruiting
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Research Team
A
Alexandre Y Poppe, MD CM
N
Nandy Simon, BSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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