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New treatment option for Stroke
Official title IntraCranial Atherosclerosis Related Large-vessel Occlusion Treated With Urgent Stenting (ICARUS)
ClinicalTrials.gov ID: NCT06472336
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
- 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
You likely can't join 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
See the full eligibility 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
- 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 treatment trial which could confound the primary endpoint
The study team makes the final eligibility decision.
Where it's taking place
- Basel, Canton of Basel-City, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basel, Canton of Basel-City, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.