💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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