Evaluating endovascular treatment for acute ischemic stroke caused by carotid artery occlusion
Evaluation of Acute Endovascular Treatment in Symptomatic Isolated Cervical Internal Carotid Artery Occlusion
This study is testing if a new treatment combining a special procedure for blocked arteries with standard care can help people who have had a stroke feel better and recover more fully.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier, Fance) |
| Trial ID | NCT05832762 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of endovascular therapy (EVT) combined with best medical treatment (BMT) against BMT alone in patients experiencing acute ischemic stroke due to cervical isolated internal carotid artery occlusion (CICAO). Participants will be assessed for functional independence at 90 days post-treatment, with additional evaluations of safety, neurological outcomes, and quality of life. The study includes patients with mild to severe strokes and specific imaging criteria indicating a mismatch in perfusion. The goal is to determine if EVT can significantly improve outcomes compared to standard treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with acute ischemic stroke symptoms and specific imaging findings indicating cervical internal carotid artery occlusion.
Not a fit: Patients with contraindications for endovascular procedures or those with significant intracranial occlusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved functional independence and reduced disability for patients suffering from acute ischemic strokes due to carotid artery occlusion.
How similar studies have performed: Previous studies have shown promising results for endovascular treatments in similar conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥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 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.
Where this trial is running
Montpellier, Fance
- Department of Neurology/ Stroke Unit, Hôpital Gui de Chauliac — Montpellier, Fance, France (Recruiting)
Study contacts
- Study coordinator: Caroline ARQUIZAN, Medical Doctor
- Email: c-arquizan@chu-montpellier.fr
- Phone: 0033467330204
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.