Clinical trial NCT06472336: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Stroke, Acute Ischemic
Intracranial Atherosclerosis
Keywords: Endovascular Treatment
Intracranial Stenting
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: Acandis GmbH
First posted: 2024-06-25
Enrollment: 498
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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
* Patients presenting within 24 hours of last seen well to the treating hospital
* 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 2 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

Primary outcomes:
measure: Assessment whether intracranial stenting compared to conventional endovascular treatment is beneficial regarding patient's functional status
timeFrame: 90 days post randomization
Secondary outcomes:
measure: Change in the National Institutes of Health Stroke Scale (NIHSS) score
timeFrame: Baseline, 24 hours, 5-7 days and, optionally, 90 days post randomization
measure: Assessment of the discharge location
timeFrame: 90 days post randomization
measure: Assessment of the cognitive function
timeFrame: 90 days post randomization
measure: Assessment of the quality of life
timeFrame: 90 and 365 days post randomization
measure: Assessment of disability and dependency in everyday live activities
timeFrame: 365 days post randomization
measure: Assessment of the residential status
timeFrame: 365 days post randomization
measure: Symptomatic intracranial haemorrhage (sICH)
timeFrame: 0-24 hours post randomization
measure: Percentage of penumbral tissue saved (imaging based outcome parameter)
timeFrame: 0 - 24 hours post randomization
measure: Grading of reperfusion at the end of the intervention (imaging based outcome parameter)
timeFrame: 0 - 60 minutes post randomization
measure: Grading of recanalization at 24 hours after the randomization (imaging based outcome parameter)
timeFrame: 24 hours post randomization
Other outcomes:
measure: Serious Adverse Events (SAEs)
timeFrame: 24 hours, 7-10 days, and 90 days post randomization
measure: All-cause mortality
timeFrame: 7-10 days, 90 days, and 365 days post randomization
measure: Reoccurrence of ischemic stroke in the same territory
timeFrame: 0-90 days post randomization
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Department of Interventional and Diagnostical Neuroradiology
state: BS
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Marios-Nikos Psychogios, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: