Phase
Condition
Stroke
Blood Clots
Thrombosis
Treatment
Best medical treatment (BMT)
Endovascular treatment (EVT) + Best medical treatment (BMT)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
≥18-year-old patients (no upper age limit)
Clinical signs consistent with AIS (Acute ischemic stroke), and time from last seenwell to randomization ≤23h
NIHSS score >5 at randomization time
Ischemic stroke confirmed by cerebral imaging (CT: Computed Tomography orMRI:Magnetic Resonance Imaging) or normal imaging with suspected ischemic stroke
Existence of a mismatch: If perfusion data are available (PWI/CTP), existence of acore-perfusion mismatch, suggestive of carotid hemodynamic mechanism, according tothe DEFUSE-3 criteria: mismatch volume ≥15 mL, core volume ≤70 mL, and mismatchratio ≥1.8 ; if perfusion data are not available, or non interpretable, existence ofa clinical-imaging mismatch, defined by an ASPECTS >5 (Alberta Stroke Program EarlyCT score)
CICAO (Cervical isolated Internal Carotid Artery Occlusion) on CTA (ComputedTomography Angiography) or MRA with gadolinium, without associated visibleipsilateral large intracranial occlusion (T or L, M1, M2, A1, A2, P1, P2), <1 hbefore randomization
Anticipated possibility to start the EVT procedure (arterial access) within 60minutes after randomization
Pre-stroke mRS score ≤2
Patient or patient's representative has received information about the study and hassigned and dated the appropriate Informed Consent or met the criteria for emergencyconsent, signed by the investigator
Exclusion
Exclusion Criteria:
CICAO after recent (<1 month) endarterectomy
Patient with severe or fatal co-morbidities or life expectancy <6 months that willlikely interfere with improvement or follow-up or that will render the procedureunlikely to benefit the patient
Patient unable to come or unavailable for follow-up
Pre-existing neurological or psychiatric disease that would confound theneurological or functional evaluations
Seizures at stroke onset if they make the diagnosis of stroke doubtful and precludeobtaining an accurate baseline NIHSS assessment
Suspected cerebral vascular disease (e.g., vasculitis) based on the medical historyand CTA/MRA
Pregnancy in progress or planned during the study period, woman who is known to bepregnant or lactating at admission time
Adult protected by law or patient under guardianship or curators
Current participation in another investigational drug or device study
Not affiliated to the French social security system or not beneficiary of suchsystem
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) ≥30days before randomization or high suspicion of chronic CICAO based on medicalhistory and CT/MRI
Tandem occlusion, defined by cervical ICA occlusion associated with intracraniallarge vessel occlusion (T- or L-shaped, M1 or M2 portions of the middle cerebralartery, A1 or A2 portions of the anterior cerebral artery, P1 or P2 portions of theposterior 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 intracranialsegment 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/andimaging
Sub-occlusive cervical ICA stenosis on CTA or MRA
Common carotid artery occlusion without ICA occlusion on non-invasive imaging (MRAor/and CTA)
Evidence of intracranial hemorrhage on CT/MRI.
Study Design
Study Description
Connect with a study center
Department of Neurology/ Stroke Unit, Hôpital Gui de Chauliac
Montpellier, Fance
FranceActive - Recruiting
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