Evaluation of Acute Endovascular Treatment in Symptomatic Isolated Cervical Internal Carotid Artery Occlusion Within 24 Hours of Last Seen Well (ETICA) (ETICA)
Ischemic Stroke, Acute
About this trial
This is an interventional treatment trial for Ischemic Stroke, Acute focused on measuring Acute ischemic Stroke; Mechanical Thrombectomy; Carotid artery; Stenting, randomized trial
Eligibility Criteria
Inclusion Criteria: ≥18-year-old patients (no upper age limit) Clinical signs consistent with AIS (Acute ischemic stroke), and time from last seen well to randomization ≤23h NIHSS score >5 at randomization time 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, existence of a clinical-imaging mismatch, defined by an ASPECTS >5 (Alberta Stroke Program Early CT score) CICAO (Cervical isolated Internal Carotid Artery Occlusion) 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 after 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. Exclusion Criteria: 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 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 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 curatorship Current participation in another investigational drug study Not affiliated to the French social security system or not beneficiary of such system Known contrast or endovascular product life-threatening allergy Associated stenosis (≥50%) of the middle cerebral artery ipsilateral to the CICAO Chronic CICAO, defined as a known carotid occlusion (on a previous imaging exam) ≥30 days before randomization 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 Prior stenting of the target ICA 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) Evidence of intracranial hemorrhage on CT/MRI.
Sites / Locations
- Department of Neurology/ Stroke Unit, Hôpital Gui de Chauliac
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Endovascular treatment + best medical treatment
best medical treatment
Endovascular treatment associated with the best medical treatment.
Best medical treatment alone