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

NCT06472336 | Recruiting DMC

• 1 other identifier: 2024-01016; th22Psychogios4
• Study Type: interventional
• Target: 498
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Stroke, Acute Ischemic; Intracranial Atherosclerosis

Keywords

Endovascular Treatment; Intracranial Stenting

Outcome Measures

Primary Outcomes (1)

• Assessment whether intracranial stenting compared to conventional endovascular treatment is beneficial regarding patient's functional status

  To evaluate whether intracranial stenting compared to conventional endovascular treatment is beneficial, the degree of disability and dependency in everyday life is measured with the modified Rankin Scale (mRS), which is a standard tool to assess the neurological outcome in trials with acute severe brain disease. The mRS ranges from 0 (no disability) to 6 (death). Lower values indicate less disability. The assessment of mRS is performed by an independent and blinded person that is certified for scoring the mRS.

  90 days post randomization

Secondary Outcomes (10)

• Change in the National Institutes of Health Stroke Scale (NIHSS) score

  Baseline, 24 hours, 5-7 days and, optionally, 90 days post randomization

• Assessment of the discharge location

  90 days post randomization

• Assessment of the cognitive function

  90 days post randomization

• Assessment of the quality of life

  90 and 365 days post randomization

• Assessment of disability and dependency in everyday live activities

  365 days post randomization

Other Outcomes (3)

• Serious Adverse Events (SAEs)

  24 hours, 7-10 days, and 90 days post randomization

• All-cause mortality

  7-10 days, 90 days, and 365 days post randomization

• Reoccurrence of ischemic stroke in the same territory

  0-90 days post randomization

Study Arms (2)

Intervention group

EXPERIMENTAL

In patients within the intervention group, the treating physician attempts to perform intracranial stenting (with or without balloon dilation).

Procedure: Intracranial stenting

Control group

ACTIVE COMPARATOR

In patients within the control group, the treating physician does not perform intracranial stenting and/or balloon dilation. Conventional endovascular therapy will be continued.

Procedure: Continuation of conventional endovascular therapy (EVT)

Interventions

Intracranial stenting PROCEDURE

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.

Intervention group

Continuation of conventional endovascular therapy (EVT) PROCEDURE

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Swiss National Science Foundation: collaborator
• Acandis GmbH: collaborator
• Phenox GmbH: collaborator

Study Sites (1)

University Hospital Basel, Department of Interventional and Diagnostical Neuroradiology

Basel, Canton of Basel-City, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Intracranial Arteriosclerosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Marios-Nikos Psychogios, Prof. Dr.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Brehm, PhD

CONTACT

+41 76 233 74 90; alex.brehm@usb.ch

Marios-Nikos Psychogios, Prof. Dr.

CONTACT

+41 61 328 59 36; marios.psychogios@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 25, 2024
• Study Start: March 31, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

CH (1)