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Carotid Artery Stenting During Endovascular Treatment of Acute Stroke

RecruitingPhase 3Ages 18 Years - anyAllUniversity Medical Center Groningen
NCT06511089 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Rationale: Approximately 20% of the patients with acute ischemic stroke due to an intracranial large vessel occlusion (LVO) has a high-grade stenosis in the ipsilateral cervical carotid artery. It is uncertain whether immediate carotid artery stenting (CAS) of a cervical carotid artery stenosis during endovascular thrombectomy (EVT) is beneficial. Immediate CAS could improve cerebral perfusion and prevent recurrent ischemic stroke but could also increase the chance of intracranial hemorrhagic complications due to hyperperfusion syndrome or to the required antiplatelet treatment to prevent stent occlusion. Moreover, some patients end up with a severe disabling stroke after EVT. In these patients carotid revascularization by carotid endarterectomy (CEA) or CAS would usually not be performed but these patients would be treated by medical management only. Objective: to assess the safety and

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Acute ischemic stroke due to proximal intracranial occlusion in the anterior circulation (intracranial ICA, M1, proximal M2) on the CT angiography 2. Stenosis \>50% according to the NASCET criteria16 or initial occlusion of the ipsilateral cervical carotid artery of presumed atherosclerotic origin on baseline CT angiography 3. Eligible for EVT according to the guidelines: EVT within 6 hours of onset or EVT between 6-24 hours after onset based on perfusion CT imaging selection (conform current guidelines) 4. Baseline National Institute of Health Stroke Scale (NIHSS) score ≥2 5. Age \>18 years 6. Written informed consent (deferred consent) Exclusion Criteria: 1. Any intracranial hemorrhage 2. Cervical carotid artery stenosis or occlusion with other causes than presumed atherosclerosis (e.g. carotid artery dissection, floating thrombus, carotid web) 3. Any exclusion criterion for EVT according to the guidelines 4. Pre stroke disability (defined as a modified Rankin Scale score \>2) 5. Recent gastro-intestinal or urinary tract hemorrhage (\<6 weeks) 6. Recent severe head trauma (\<6 weeks) 7. Recent infarction on baseline brain CT in the same vascular territory (\<6 weeks) 8. Known allergy to aspirin and/or clopidogrel 9. Pregnancy
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What it tests

  • carotid artery stenting during EVT
  • no carotid artery stenting during EVT
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Where

1 site
University Medical Center Groningen
Groningen, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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