Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06472336

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

Sponsor: University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

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.

Official title: IntraCranial Atherosclerosis Related Large-vessel Occlusion Treated With Urgent Stenting - a Pragmatic, International, Multicentre, Randomized Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

498

Start Date

2025-03-31

Completion Date

2027-08

Last Updated

2025-12-17

Healthy Volunteers

Conditions

Stroke Stroke, Acute Ischemic Intracranial Atherosclerosis

Interventions

PROCEDURE

Intracranial stenting

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.

PROCEDURE

Continuation of conventional endovascular therapy (EVT)

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.

Inclusion Criteria: * 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 Criteria: * 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

Locations (1)

University Hospital Basel, Department of Interventional and Diagnostical Neuroradiology

Basel, Canton of Basel-City, Switzerland