IntraCranial Atherosclerosis Related Large-vessel Occlusion Treated With Urgent Stenting (ICARUS)
NCT ID: NCT06472336
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
498 participants
INTERVENTIONAL
2025-03-31
2027-08-31
Brief Summary
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Detailed Description
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One potential solution for these cases is intracranial stenting, where a stent is permanently implanted in the affected blood vessel to restore blood flow to the brain. This approach has shown promise in other conditions like myocardial infarction. However, there is an ongoing debate whether the benefits are offset by possibly higher bleeding risk, and current guidelines don't provide clear recommendations on the use of intracranial stenting.
Therefore, this study aims to compare the clinical efficacy and safety of early intracranial stenting versus continued conventional EVT (stent-retriever or aspiration based) in LVO stroke patients who haven't responded to conventional EVT due to ICAD.
The results of this clinical trial will offer high quality clinical evidence to determine whether intracranial stenting provides benefits over conventional EVT for LVO stroke patients experiencing recanalisation failure due to ICAD.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention group
In patients within the intervention group, the treating physician attempts to perform intracranial stenting (with or without balloon dilation).
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.
Control group
In patients within the control group, the treating physician does not perform intracranial stenting and/or balloon dilation. Conventional endovascular therapy will be continued.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Swiss National Science Foundation
OTHER
Acandis GmbH
INDUSTRY
Phenox GmbH
INDUSTRY
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Marios-Nikos Psychogios, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
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University Hospital Basel, Department of Interventional and Diagnostical Neuroradiology
Basel, Canton of Basel-City, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-01016; th22Psychogios4
Identifier Type: -
Identifier Source: org_study_id