About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
carotid artery stenting during EVT
Procedure/SurgeryPatients with an ipsilateral high grade carotid artery stenosis or occlusion of presumed atherosclerotic origin and an proximal intracranial large vessel occlusion in the anterior circulation will be randomized using a web-based randomization tool to immediate carotid artery stenting or deferred treatment strategy of carotid artery stenosis. In the intervention group, the cervical carotid artery lesion will be treated with a stent during the EVT (just before or directly after intracranial thrombus removal), the control group will be treated according to the national guidelines with carotid endarterectomy of carotid artery stenting (for patients with non-disabling stroke) or medical management alone (for patients with severe disabling stroke).
no carotid artery stenting during EVT
Other interventionA deferred treatment approach: carotid revascularization within two weeks after stroke onset or best medical management only, depending on the functional recovery of the patient.
Treatment groups
Trial outcomes
Primary outcomes
Modified Rankin Scale score
Stroke-related disability measured using the Modified Rankin Scale (mRS) Score at 90 days after stroke onset.
Secondary outcomes
NIHSS score 24 hours
Stroke severity
TICI score
Recanalization after EVT
Final infarct volume on brain CT scan at 24 hours
Final infarct volume on brain CT scan at 24 hours
Arterial occlusive lesion score at 24 hours
Arterial occlusive lesion score at 24 hours
Other outcomes
Symptomatic Intracranial hemorrhage
Symptomatic Intracranial hemorrhage
Any intracranial hemorrhage
Any intracranial hemorrhage
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Medical Center Groningen
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborator