Evaluation of Acute Endovascular Treatment in Symptomatic Isolated Cervical Internal Carotid Artery Occlusion Within 24 Hours of Last Seen Well (ETICA)
- Conditions
- Acute Ischemic Stroke
- Registration Number
- NCT05832762
- Lead Sponsor
- University Hospital, Montpellier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - =18-year-old patients (no upper age limit)<br><br> - Clinical signs consistent with AIS (Acute ischemic stroke), and time from last seen<br> well to randomization =23h<br><br> - NIHSS score >5 at randomization time<br><br> - Ischemic stroke confirmed by cerebral imaging (CT: Computed Tomography or<br> MRI:Magnetic Resonance Imaging) or normal imaging with suspected ischemic stroke<br><br> - Existence of a mismatch: If perfusion data are available (PWI/CTP), existence of a<br> core-perfusion mismatch, suggestive of carotid hemodynamic mechanism, according to<br> the DEFUSE-3 criteria: mismatch volume =15 mL, core volume =70 mL, and mismatch<br> ratio =1.8 ; if perfusion data are not available, existence of a clinical-imaging<br> mismatch, defined by an ASPECTS >5 (Alberta Stroke Program Early CT score)<br><br> - CICAO (Cervical isolated Internal Carotid Artery Occlusion) on CTA (Computed<br> Tomography Angiography) or MRA with gadolinium, without associated visible<br> ipsilateral large intracranial occlusion (T or L, M1, M2, A1, A2, P1, P2), <1 h<br> after randomization<br><br> - Anticipated possibility to start the EVT procedure (arterial access) within 60<br> minutes after randomization<br><br> - Pre-stroke mRS score =2<br><br> - Patient or patient's representative has received information about the study and has<br> signed and dated the appropriate Informed Consent or met the criteria for emergency<br> consent.<br><br>Exclusion Criteria:<br><br> - CICAO after recent (<1 month) endarterectomy<br><br> - Patient with severe or fatal co-morbidities or life expectancy <6 months that will<br> likely interfere with improvement or follow-up or that will render the procedure<br> unlikely to benefit the patient<br><br> - Patient unable to come or unavailable for follow-up<br><br> - Pre-existing neurological or psychiatric disease that would confound the<br> neurological or functional evaluations<br><br> - Seizures at stroke onset if they make the diagnosis of stroke doubtful and preclude<br> obtaining an accurate baseline NIHSS assessment<br><br> - Suspected cerebral vascular disease (e.g., vasculitis) based on the medical history<br> and CTA/MRA<br><br> - Pregnancy in progress or planned during the study period, woman who is known to be<br> pregnant or lactating at admission time<br><br> - Adult protected by law or patient under guardianship or curators<br><br> - Current participation in another investigational drug study<br><br> - Not affiliated to the French social security system or not beneficiary of such<br> system<br><br> - Known contrast or endovascular product life-threatening allergy<br><br> - Associated stenosis (=50%) of the middle cerebral artery ipsilateral to the CICAO<br><br> - Chronic CICAO, defined as a known carotid occlusion (on a previous imaging exam) =30<br> days before randomization<br><br> - Tandem occlusion, defined by cervical ICA occlusion associated with intracranial<br> large vessel occlusion (T- or L-shaped, M1 or M2 portions of the middle cerebral<br> artery, A1 or A2 portions of the anterior cerebral artery, P1 or P2 portions of the<br> posterior cerebral artery)<br><br> - Associated ipsilateral large intracranial arterial occlusion<br><br> - Prior stenting of the target ICA<br><br> - Intracranial stent implanted in the same vascular territory as the CICAO<br><br> - Sub-occlusive cervical ICA stenosis on CTA or MRA<br><br> - Suspicion of ICA occlusion starting at the petrous, cavernous or intracranial<br> segment with normal cervical portion on non-invasive imaging (MRA or/and CTA)<br><br> - Known absence of vascular access<br><br> - Suspicion of aortic dissection based on medical history, clinical evaluation or/and<br> imaging<br><br> - Sub-occlusive cervical ICA stenosis on CTA or MRA<br><br> - Common carotid artery occlusion without ICA occlusion on non-invasive imaging (MRA<br> or/and CTA)<br><br> - Evidence of intracranial hemorrhage on CT/MRI.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with favorable functional outcome, defined by a mRS score =2
- Secondary Outcome Measures
Name Time Method Percentage of patients with excellent outcome (mRS score = 0-1);Change in NIHSS score at 24 (-6/+12) hours post-randomization.;Quality of life assessed with the EuroQol 5D-5L;Cognitive function at day 90 (±14), evaluated with the Montreal Cognitive assessment (MoCA test).;Ischemic recurrence rate;Ischemic recurrence rate;Ischemic recurrence rate;Carotid artery revascularization rate;Carotid artery recanalization rate;Carotid artery recanalization rate;Infarct volume;Infarct volume;Early neurological change;Incidence of all-cause mortality at day 90;Incidence of symptomatic intracranial hemorrhage;Incidence of procedure/device-related adverse events;Early neurological deterioration rate;Neurological deterioration rate;Rapid NIHSS worsening