Carotid Artery Stenting During Endovascular Treatment of Acute Stroke

Recruiting now · Phase 3

Conditions studied: Stroke, Acute, Stroke, Ischemic, Carotid Stenosis, Carotid Atherosclerosis, Carotid Occlusion

In brief

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 efficacy of immediate cervical CAS during EVT in patients with acute ischemic stroke due to LVO with a high-grade stenosis \>50% or occlusion of the ipsilateral cervical carotid artery. Study design: prospective randomized open label controlled trial comparing immediate CAS during EVT versus EVT with deferred treatment of the cervical carotid artery lesion (deferred CAS/CEA or medical management alone). Outcome assessment will be blinded for treatment allocation.

Key facts

Study ID

NCT06511089

Run by

University Medical Center Groningen

People needed

600

Starts

2022-11-15

Expected to finish

2026-11-15

Last updated by the study team

2024-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Acute ischemic stroke due to proximal intracranial occlusion in the anterior circulation (intracranial ICA, M1, proximal M2) on the CT angiography
• Stenosis >50% according to the NASCET criteria16 or initial occlusion of the ipsilateral cervical carotid artery of presumed atherosclerotic origin on baseline CT angiography
• 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)
• Baseline National Institute of Health Stroke Scale (NIHSS) score ≥2
• Age >18 years
• Written informed consent (deferred consent)

You may not qualify if…

• Any intracranial hemorrhage
• Cervical carotid artery stenosis or occlusion with other causes than presumed atherosclerosis (e.g. carotid artery dissection, floating thrombus, carotid web)
• Any exclusion criterion for EVT according to the guidelines
• Pre stroke disability (defined as a modified Rankin Scale score >2)
• Recent gastro-intestinal or urinary tract hemorrhage (<6 weeks)
• Recent severe head trauma (<6 weeks)
• Recent infarction on baseline brain CT in the same vascular territory (<6 weeks)
• Known allergy to aspirin and/or clopidogrel
• Pregnancy

Where it is running

• University Medical Center Groningen — Groningen, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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