IntraCranial Atherosclerosis Related Large-vessel Occlusion Treated With Urgent Stenting (ICARUS)
IntraCranial Atherosclerosis Related Large-vessel Occlusion Treated With Urgent Stenting - a Pragmatic, International, Multicentre, Randomized Trial
University Hospital, Basel, Switzerland
498 participants
Mar 31, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this international, multi-center, randomized clinical trial is to compare two treatment options, early intracranial stenting and continued stent-retriever or aspiration based endovascular treatment, for stroke patients with a large vessel occlusion, who experienced failure of recanalisation after initial treatment due to intracranial atherosclerosis.
Eligibility
Inclusion Criteria9
- A relevant clinical deficit defined as a National Institute of Health Stoke Scale (NIHSS) Score of ≥ 6 points for anterior circulation stroke and a NIHSS Score of ≥ 10 for posterior circulation stroke
- Anticipated randomization within 24 hours of last seen well (LSW)
- Occlusion of the Internal Carotid Artery, the M1 segment, the proximal/dominant M2 segment of the Middle Cerebral Artery, the Basilar Artery or the V4 segment of the Vertebral Artery
- Absence of recanalization (thrombolysis in myocardial infarction score of 0 or 1) after up to three endovascular treatment passes
- High probability of underlying intracranial atherosclerotic disease based on the assessment of the treating physician
- Age ≥ 18 years
- Occluded artery amendable to stenting by judgement of the treating physician
- Absence of a large infarct core defined as (posterior circulation) Alberta Stroke Program Early CT Score of 6 or above
- Informed Consent as documented by signature or fulfilling the criteria for emergency consent procedures
Exclusion Criteria13
- Acute intracranial haemorrhage
- Pre-stroke modified Rankin Scale score of 3 or above
- Known, severe comorbidities, which will likely prevent improvement or follow-up (cancer, alcohol/drug abuse or dementia)
- Known clotting disease or suspicion of underlying disease which might lead to a hyper coagulant state
- In-hospital Stroke
- Known contraindications for anti-platelet therapy
- Known (serious) sensitivity to radiographic contrast agents, nickel, titanium metals or their alloys
- Foreseeable difficulties in follow-up due to geographic reasons (e.g., patients living abroad)
- Evidence of an ongoing pregnancy prior to randomization
- Radiological confirmed evidence of mass effect or intracranial tumour (except small meningioma)
- Radiological confirmed evidence of cerebral vasculitis
- Evidence of vessel recanalization prior to randomisation
- Participation in another interventional trial which could confound the primary endpoint
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Interventions
Intracranial stenting (+/- balloon dilatation) will be performed. Decisions regarding intracranial stenting are solely made by the treating physician. This means in specific, that the treating physician decides based on his/her judgement or based on local standards (as reported in the literature) on the devices and/or concomitant medications (including infusion/administration of antiplatelet medicine) used for intracranial stenting.
Patients undergo either (a) continued stent retriever or contact aspiration based endovascular treatment manoeuvres, (b) infusion/administration of antiplatelet medication or (c) stop of the procedure depending on local standard treatment approaches.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06472336