New stroke treatment shows promise in early trial
NCT ID NCT05832762
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a procedure to remove a blockage in the neck artery (endovascular treatment) plus standard medical care helps people recover better after a stroke. About 200 adults with acute ischemic stroke from a blocked internal carotid artery will be randomly assigned to get the procedure or just medical care. The main goal is to see if more people are independent (able to do daily activities) 90 days later.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Endovascular treatment (catheter-based procedure to remove clot or open artery)
- What this could lead to
- If successful, this could provide a better treatment option for certain stroke patients, reducing long-term disability.
- What could go wrong
- This is a relatively small, early-stage trial. The procedure carries risks like bleeding or vessel damage, and results may not apply to all stroke patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Neurology/ Stroke Unit, Hôpital Gui de Chauliac
RECRUITINGMontpellier, Fance, France
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