Informations générales (source: ClinicalTrials.gov)
Evaluation of Acute Endovascular Treatment in Symptomatic Isolated Cervical Internal Carotid Artery Occlusion Within 24 Hours of Last Seen Well
Interventional
N/A
University Hospital, Montpellier (Voir sur ClinicalTrials)
août 2024
novembre 2026
02 décembre 2025
Our main hypothesis is that acute EVT associated with best medical treatment is superior
to best medical treatment alone, for improving clinical outcomes at 90 days, in patients
with mild or severe acute ischemique stroke and diffusion-perfusion or clinical-imaging
mismatch, secondary to CICAO.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | BERTRAND LAPERGUE | 15/12/2025 08:26:47 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| HOPITAL FONDATION A. DE ROTHSCHILD | vendredi 21 juin 2024 | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Department of Neurology/ Stroke Unit, Hôpital Gui de Chauliac - Montpellier 2992166 - Fance - France | Caroline ARQUIZAN, Medical Doctor | Contact (sur clinicalTrials) | |||
Critères
Tous
- ≥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, 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) 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
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 curators
- Current participation in another investigational drug or device 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 or high suspicion of chronic CICAO based on medical
history and CT/MRI
- 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.