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

Launched by UNIVERSITY HOSPITAL, BASEL, SWITZERLAND · Jun 24, 2024

Keywords

ClinConnect Summary

The ICARUS trial is a research study aimed at finding the best way to treat stroke patients who have a blockage in a large blood vessel in the brain due to a condition called intracranial atherosclerosis. This study compares two treatment methods: one involves placing a stent (a small mesh tube) in the affected area right away, while the other continues using a technique called endovascular treatment, which includes stent-retriever or aspiration methods. The trial is open to patients who have had a stroke and meet specific criteria, such as showing significant symptoms and having a blockage in certain blood vessels within 24 hours of their last normal state.

Eligible participants are adults aged 18 and older who have a specific level of stroke severity and have not experienced improvement after initial treatment. They should not have serious health issues that could affect their recovery or follow-up. Those who join the study can expect close monitoring and care as they receive one of the two treatments. This research is important because it seeks to improve outcomes for stroke patients by determining which treatment option may be more effective in reopening blocked blood vessels in the brain.

Gender

ALL

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