IntraCranial Atherosclerosis Related Large-vessel Occlusion Treated With Urgent Stenting (ICARUS)

Recruiting now · Not applicable

Conditions studied: Stroke, Stroke, Acute Ischemic, Intracranial Atherosclerosis

In brief

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.

Key facts

Study ID

NCT06472336

Run by

University Hospital, Basel, Switzerland

People needed

498

Starts

2025-03-31

Expected to finish

2027-08-01

Last updated by the study team

2025-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University Hospital Basel, Department of Interventional and Diagnostical Neuroradiology — Basel, Canton of Basel-City, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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