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

Official title

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

Overview

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.

Detailed description

This clinical tiral focuses on comparing treatment options for patients with an acute ischemic stroke, which is a significant cause of death and disability worldwide. Currently, endovascular treatment (EVT) is the gold standard for the removal of large blood clots in the brain arteries (large vessel occlusion, LVO), but sometimes it fails to reopen blocked blood vessels, especially when caused by an underlying intracranial atherosclerosis (ICAD). When restoring blood flow fails, patients' outcomes are much worse, with more than 70% experiencing severe disability or death.

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.

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.

Primary outcome measures

• Assessment whether intracranial stenting compared to conventional endovascular treatment is beneficial regarding patient's functional status [Time frame: 90 days post randomization]

Secondary outcome measures (10)

• Change in the National Institutes of Health Stroke Scale (NIHSS) score [Time frame: Baseline, 24 hours, 5-7 days and, optionally, 90 days post randomization]
• Assessment of the discharge location [Time frame: 90 days post randomization]
• Assessment of the cognitive function [Time frame: 90 days post randomization]
• Assessment of the quality of life [Time frame: 90 and 365 days post randomization]
• Assessment of disability and dependency in everyday live activities [Time frame: 365 days post randomization]
• Assessment of the residential status [Time frame: 365 days post randomization]
• Symptomatic intracranial haemorrhage (sICH) [Time frame: 0-24 hours post randomization]
• Percentage of penumbral tissue saved (imaging based outcome parameter) [Time frame: 0 - 24 hours post randomization]
• Grading of reperfusion at the end of the intervention (imaging based outcome parameter) [Time frame: 0 - 60 minutes post randomization]
• Grading of recanalization at 24 hours after the randomization (imaging based outcome parameter) [Time frame: 24 hours post randomization]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Switzerland · 1 center

• University Hospital Basel, Department of Interventional and Diagnostical Neuroradiology — Basel

Identifiers

NCT: NCT06472336 · 2024-01016; th22Psychogios4

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗