Actively Recruiting
IntraCranial Atherosclerosis Related Large-vessel Occlusion Treated With Urgent Stenting - a Pragmatic, International, Multicentre, Randomized Trial
Led by University Hospital, Basel, Switzerland · Updated on 2025-12-17
498
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Basel, Switzerland
Lead Sponsor
S
Swiss National Science Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial investigates treatment options for patients who have had an acute ischemic stroke caused by a large vessel blockage in the brain and have not responded to initial treatment due to intracranial atherosclerosis. Researchers aim to compare early intracranial stenting against continued conventional endovascular therapy to see which approach better improves patient outcomes. The study addresses a critical need as unsuccessful vessel reopening often leads to severe disability or death. Participants are randomly assigned to one of two groups. In the intervention group, doctors will attempt to place a stent inside the blocked brain artery, with or without balloon dilation, to restore blood flow. In the control group, doctors continue conventional endovascular treatment methods like stent retriever or aspiration techniques without stenting. The decision on specific devices and medications during stenting is made by the treating physician based on judgment and local standards. Participants are evaluated at multiple points, including baseline, 24 hours, 5 to 7 days, and up to 365 days after randomization. Assessments include stroke severity scores, cognitive function, quality of life, disability, and imaging tests to measure blood flow restoration and brain tissue saved. The main outcome is the patient’s functional status 90 days after treatment. The study also monitors safety events such as bleeding within the brain and tracks longer-term recovery measures.
CONDITIONS
Brief Title
IntraCranial Atherosclerosis Related Large-vessel Occlusion Treated With Urgent Stenting (ICARUS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- National Institute of Health Stroke Scale (NIHSS) score of 6 or higher for anterior circulation stroke or 10 or higher for posterior circulation stroke
- Expected randomization within 24 hours of last seen well
- Blockage in Internal Carotid Artery, M1 segment, proximal/dominant M2 segment of Middle Cerebral Artery, Basilar Artery, or V4 segment of Vertebral Artery
- No vessel recanalization after up to three endovascular treatment passes
- High likelihood of intracranial atherosclerotic disease as judged by treating physician
- Age 18 years or older
- Blocked artery suitable for stenting by physician's judgment
- No large infarct core with Alberta Stroke Program Early CT Score of 6 or above
- Informed consent obtained or emergency consent procedures met
You will not qualify if you...
- Acute bleeding inside the brain
- Pre-stroke modified Rankin Scale score of 3 or higher
- Severe comorbidities expected to prevent improvement or follow-up (such as cancer, alcohol/drug abuse, or dementia)
- Known clotting disorders or suspected hypercoagulable states
- Stroke occurring during hospital stay
- Contraindications to antiplatelet therapy
- Known serious allergies to contrast agents, nickel, titanium, or their alloys
- Expected difficulties in follow-up due to geographic reasons
- Pregnancy before randomization
- Brain swelling or tumors seen on scans (except small meningioma)
- Evidence of cerebral vasculitis on imaging
- Vessel reopening before randomization
- Participation in another interventional trial that could affect outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 24 hours
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 24 hours or until procedure completion
Participants receive either intracranial stenting (with or without balloon dilation) or continued conventional endovascular therapy to restore blood flow after failure of initial treatment for large vessel occlusion stroke due to intracranial atherosclerosis.
1 treatment procedure visit (in-person)
Duration - Up to 365 days
Participants are monitored to assess functional status, neurological outcomes, and safety after treatment.
Visits at 24 hours, 5-7 days, 90 days, and 365 days post randomization
Trial Site Locations
Total: 1 location
1
University Hospital Basel, Department of Interventional and Diagnostical Neuroradiology
Basel, Canton of Basel-City, Switzerland, 4031
Actively Recruiting
Research Team
A
Alex Brehm, PhD
M
Marios-Nikos Psychogios, Prof. Dr.
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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