Evaluation of Acute Endovascular Treatment in Symptomatic Isolated Cervical Internal Carotid Artery Occlusion (ETICA)

Ki vehet részt

• ≥18-year-old patients (no upper age limit)
• Clinical signs consistent with AIS (Acute ischemic stroke)
• NIHSS score >5 at randomization time with time from last seen well to randomization ≤23h, or fluctuating neurological symptoms, defined as recurrent transient attacks and/or progression of neurological deficit within the last 7 days
• Ischemic stroke confirmed by cerebral imaging (CT: Computed Tomography or MRI:Magnetic Resonance Imaging) or normal imaging with suspected ischemic stroke
• Existence of a mismatch: If perfusion data are available (PWI/CTP), existence of a core-perfusion mismatch, suggestive of carotid hemodynamic mechanism, according to the DEFUSE-3 criteria: mismatch volume ≥15 mL, core volume ≤70 mL, and mismatch ratio ≥1.8 ; if perfusion data are not available, or non interpretable, existence of a clinical-imaging mismatch, defined by an ASPECTS >5 (Alberta Stroke Program Early CT score)
• CICAO (Cervical isolated Internal Carotid Artery Occlusion) all causes (for example dissection, atheroma or undetermined cause) on CTA (Computed Tomography Angiography) or MRA with gadolinium, without associated visible ipsilateral large intracranial occlusion (T or L, M1, M2, A1, A2, P1, P2), <1 h before randomization
• Anticipated possibility to start the EVT procedure (arterial access) within 60 minutes after randomization
• Pre-stroke mRS score ≤2
• Patient or patient's representative has received information about the study and has signed and dated the appropriate Informed Consent or met the criteria for emergency consent, signed by the investigator

Ki nem vehet részt

• Current participation in another investigational drug or device study
• Chronic CICAO, defined as a known carotid occlusion (on a previous imaging exam) ≥30 days before randomization or high suspicion of chronic CICAO based on medical history and CT/MRI
• Prior stenting of the target ICA
• Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations
• Seizures at stroke onset if they make the diagnosis of stroke doubtful and preclude obtaining an accurate baseline NIHSS assessment
• Suspected cerebral vascular disease (e.g., vasculitis) based on the medical history and CTA/MRA
• Known contrast or endovascular product life-threatening allergy
• Evidence of intracranial hemorrhage on CT/MRI
• CICAO after recent (<1 month) endarterectomy
• Patient with severe or fatal co-morbidities or life expectancy <6 months that will likely interfere with improvement or follow-up or that will render the procedure unlikely to benefit the patient
• Patient unable to come or unavailable for follow-up
• Pregnancy in progress or planned during the study period, woman who is known to be pregnant or lactating at admission time
• Adult protected by law or patient under guardianship or curators
• Not affiliated to the French social security system or not beneficiary of such system
• Associated stenosis (≥50%) of the middle cerebral artery ipsilateral to the CICAO
• Tandem occlusion, defined by cervical ICA occlusion associated with intracranial large vessel occlusion (T- or L-shaped, M1 or M2 portions of the middle cerebral artery, A1 or A2 portions of the anterior cerebral artery, P1 or P2 portions of the posterior cerebral artery)
• Associated ipsilateral large intracranial arterial occlusion
• Intracranial stent implanted in the same vascular territory as the CICAO
• Sub-occlusive cervical ICA stenosis on CTA or MRA
• Suspicion of ICA occlusion starting at the petrous, cavernous or intracranial segment with normal cervical portion on non-invasive imaging (MRA or/and CTA)
• Known absence of vascular access
• Suspicion of aortic dissection based on medical history, clinical evaluation or/and imaging
• Sub-occlusive cervical ICA stenosis on CTA or MRA
• Common carotid artery occlusion without ICA occlusion on non-invasive imaging (MRA or/and CTA)