Acute Ischemic StrokeETICANCT05832762
Evaluation of Acute Endovascular Treatment in Symptomatic Isolated Cervical Internal Carotid Artery Occlusion (ETICA)
A study testing Endovascular treatment (EVT) + Best medical treatment (BMT) and Best medical treatment (BMT) in people with Acute Ischemic Stroke, run by University Hospital, Montpellier at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Endovascular treatment (EVT) + Best medical treatment (BMT) and Best medical treatment (BMT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 19 Aug 2024to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
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- 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
Who cannot join
- 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
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Department of Neurology/ Stroke Unit, Hôpital Gui de Chauliac
Montpellier, Fance
Caroline ARQUIZAN, Medical Doctor, 0033467330204, c-arquizan@chu-montpellier.fr
COSTALAT Vincent, Medical Doctor, 0033467337532, v-costalat@chu-montpellier.fr
About this study
Official title: Evaluation of Acute Endovascular Treatment in Symptomatic Isolated Cervical Internal Carotid Artery Occlusion
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.
Read the detailed description
The primary objective of this study is to demonstrate the superiority of endovascular therapy (EVT) associated with best medical therapy (BMT) (experimental arm) compared to BMT alone (control arm) to increase the functional independence at day 90 3 months (mRS 0-2) in patients with acute cervical isolated internal carotid artery occlusion (CICAO), mild to severe stroke (NIHSS score > 5), and core-perfusion or clinical-imaging mismatch.
Secondary objectives are,(i) to compare the safety of EVT + BMT vs. BMT alone in patients with AIS secondary to CICAO and core-perfusion of clinical imaging mismatch; (ii) to demonstrate the superiority of EVT + BMT vs BMT alone on : the rate of excellent outcome at 3 months (modified Rankin Scale, mRS, score = 0-1),the decrease of the 90-day degree of disability (shift on the mRS combining scores of 5 and 6), the rate of carotid recanalization at 24 hours and at day 90 post-randomization, the cerebral infarct size at 24 hours and at day 90 post-randomization, the early neurological deterioration rate at 24 hours and at day 5- 7 post-randomization, the ischemic recurrences rate at day 90 post-randomization, the early neurological improvement rate at 24h hours post-randomization, the cognitive impairment rate at day 90 post-randomization, the Quality of life at day 90 post-randomization.
One of the secondary objective is also to describe in the experimental group (EVT + BMT), the procedure-related adverse events at day 90 ((Embolism to an intracranial artery, vascular perforation, arterial dissection, access site complication requiring surgical repair or blood transfusion, peri-procedural mortality, device failure).
- Conditions
- Acute Ischemic Stroke
- Being tested
- Endovascular treatment (EVT) + Best medical treatment (BMT), Best medical treatment (BMT)
- Keywords
- Acute ischemic Stroke, Mechanical Thrombectomy, Carotid artery, Stenting, Randomized trial
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular treatment (EVT) + Best medical treatment (BMT)Procedure or surgery
Endovascular treatment (EVT) in the experimental arm can be performed with any recanalization strategy based on the operator's choice, and anatomical and radiological situation: MT using aspiration or stent retriever, with or without stenting (CE-labelled) or angioplasty. In case of acute stenting, the use of antiplatelet drugs will be based on the operator's preference, anatomical situation, and risk of hemorrhage.
Best medical treatment (BMT) : Administration of drugs is at the treating physician's discretion (for example, intravenous fibrinolysis, anticoagulants, or antiplatelet agents) according to the local standards of care, but not intra-arterial therapies.
Best medical treatment (BMT)Procedure or surgery
Administration of drugs is at the treating physician's discretion (for example, intravenous fibrinolysis, anticoagulants, or antiplatelet agents) according to the local standards of care, but not intra-arterial therapies.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular treatment + best medical treatment | Experimental | Endovascular treatment associated with the best medical treatment. Receives: Procedure: Endovascular treatment (EVT) + Best medical treatment (BMT) |
| best medical treatment | Active comparator | Best medical treatment alone Receives: Procedure: Best medical treatment (BMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with favorable functional outcome, defined by a mRS score ≤2
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.The scale runs from "0" to "6", running from perfect health without symptoms to death.
The mRS score will be evaluated by qualified assessors blinded to the initial treatment.The blinded evaluator must be familiar with mRS scoring (dedicated training and certification). If a participant is unable to attend in-person the follow-up visit at day 90 (±15), mRS scoring can be done by telephone by a qualified investigator.
Measured: Day 90 (± 15 days) post-randomization
Secondary outcomes (18)
The degree of disability at day 90 (±15) post-randomization (shift on the mRS combining scores of 5 and 6)
The mRS score will be evaluated by qualified assessors blinded to the initial treatment.The blinded evaluator must be familiar with mRS scoring (dedicated training and certification). If a participant is unable to attend in-person the follow-up visit at day 90 (±15), mRS scoring can be done by telephone by a qualified investigator.
Measured: Day 90 (± 15 days) post-randomization
Change in NIHSS score at 24 (-6/+12) hours post-randomization.
NIHSS score is "the National Institutes of Health Stroke Scale". The NIHSS is composed of 11 items, each of which scores a specific ability between 0 and 4. For each item, a score of 0 typically indicates normal function, while higher scores are indicative of some level of impairment. The individual scores for each item are summed to calculate the patient's total NIHSS score. The maximum possible score is 42, and the minimum score is 0.
Measured: 24h (-6/+12) post-randomization
Quality of life at day 90 (±15) post-randomization assessed with the EuroQol 5D-5L
Assessed with the EuroQol 5D-5L which comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Measured: Day 90 (± 15 days) post-randomization
Cognitive function at day 90 (±15) post-randomization, evaluated with the Montreal Cognitive assessment (MoCA test).
The MoCA test is the Montreal Cognitive Assessment measuring the neurocognitive function. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal. This test covers orientation, short-term memory, focus and spatial awareness, language, concentration and clock drawing test.
Measured: Day 90 (±15 days) post randomization
Carotid artery revascularization rate
Assessed by angiography in the experimental arm, defined by complete recanalization or residual carotid artery stenosis <50%
Measured: randomization
Carotid artery recanalization rate
Assessed by MRA with gadolinium or CTA, defined as complete recanalization or residual carotid artery stenosis <50%
Measured: 24 (-6/+12) hours post randomization
Carotid artery recanalization rate
Assessed by MRA with gadolinium or CTA, defined as complete recanalization or residual carotid artery stenosis <50%
Measured: Day 90 (± 15 days) post-randomization
Infarct volume
Measured by magnetic resonance angiography (MRI, FLAIR) or computed tomography (CT).
Measured: 24 (-6/+12) hours post randomization
Infarct volume
Measured by magnetic resonance angiography (MRI, FLAIR) or computed tomography (CT).
Measured: Day 90 (± 15 days) post randomization
Early neurological improvement
Early neurological improvementis defined by an NIHSS score of 0-2 at 24 hours or a ≥8-point decrease of the NIHSS score at 24 hours compared with baseline.
Measured: Day 0 - 24 hours post randomization
Incidence of all-cause mortality at day 90
Incidence of all-cause mortality at day 90
Measured: Day 90 (± 15 days) post randomization
Rate of symptomatic intracranial hemorrhage
According to the Heidelberg Bleeding classification by cerebral imaging
Measured: 24 (-6/+12) hours post-randomization
Incidence of procedure/device-related adverse events
In the experimental group (EVT + BMT)
Measured: Day 30 (±5 days) post randomization
Early neurological deterioration rate
NIHSS score increase by ≥4 points
Measured: 24 hours post-randomization
Neurological deterioration rate
NIHSS score increase by ≥4 points
Measured: Day 5-7 post randomization
Rapid NIHSS worsening
NIHSS score increase by ≥10 points
Measured: Admission - day 5/day 7/discharge (if earlier)
Degree of disability at day 30 post-randomization (shift on the mRS combining scores of 5 and 6)
The mRS score will be evaluated by qualified assessors.The evaluator must be familiar with mRS scoring (dedicated training and certification). If a participant is unable to attend in-person the follow-up visit at day 30, mRS scoring can be done by telephone by a qualified investigator.
Measured: Day 30 (±5 days) post randomization
Incidence of symptomatic intracranial hemorrhage according to the SITS-MOST
Measured: Day 90 (±15 days) post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start19 Aug 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The protocol is a national, multi-center, prospectively randomized into two parallel (1:1) arms, open to treatment with blinded endpoint trial (PROBE)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832762
- Sponsor's protocol ID
- RECHMPL21_0527
- Acronym
- ETICA
- Status last verified
- Jan 2026
- First submitted
- 14 Apr 2023
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Acute Endovascular Treatment in Symptomatic Isolated Cervical Internal Carotid Artery Occlusion
- ClinicalTrials.gov ID
- NCT05832762
- Acronym / sponsor ID
- ETICA / RECHMPL21_0527
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute ischemic Stroke, Mechanical Thrombectomy, Carotid artery, Stenting, Randomized trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective of this study is to demonstrate the superiority of endovascular therapy (EVT) associated with best medical therapy (BMT) (experimental arm) compared to BMT alone (control arm) to increase the functional independence at day 90 3 months (mRS 0-2) in patients with acute cervical isolated internal carotid artery occlusion (CICAO), mild to severe stroke (NIHSS score > 5), and core-perfusion or clinical-imaging mismatch.
Secondary objectives are,(i) to compare the safety of EVT + BMT vs. BMT alone in patients with AIS secondary to CICAO and core-perfusion of clinical imaging mismatch; (ii) to demonstrate the superiority of EVT + BMT vs BMT alone on : the rate of excellent outcome at 3 months (modified Rankin Scale, mRS, score = 0-1),the decrease of the 90-day degree of disability (shift on the mRS combining scores of 5 and 6), the rate of carotid recanalization at 24 hours and at day 90 post-randomization, the cerebral infarct size at 24 hours and at day 90 post-randomization, the early neurological deterioration rate at 24 hours and at day 5- 7 post-randomization, the ischemic recurrences rate at day 90 post-randomization, the early neurological improvement rate at 24h hours post-randomization, the cognitive impairment rate at day 90 post-randomization, the Quality of life at day 90 post-randomization.
One of the secondary objective is also to describe in the experimental group (EVT + BMT), the procedure-related adverse events at day 90 ((Embolism to an intracranial artery, vascular perforation, arterial dissection, access site complication requiring surgical repair or blood transfusion, peri-procedural mortality, device failure).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The protocol is a national, multi-center, prospectively randomized into two parallel (1:1) arms, open to treatment with blinded endpoint trial (PROBE)
| Arm | Type | Receives |
|---|---|---|
| Endovascular treatment + best medical treatment | Experimental | Procedure: Endovascular treatment (EVT) + Best medical treatment (BMT)Endovascular treatment associated with the best medical treatment. |
| best medical treatment | Active comparator | Procedure: Best medical treatment (BMT)Best medical treatment alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥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)
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular treatment (EVT) + Best medical treatment (BMT)Endovascular treatment (EVT) in the experimental arm can be performed with any recanalization strategy based on the operator's choice, and anatomical and radiological situation: MT using aspiration or stent retriever, with or without stenting (CE-labelled) or angioplasty. In case of acute stenting, the use of antiplatelet drugs will be based on the operator's preference, anatomical situation, and risk of hemorrhage. Best medical treatment (BMT) : Administration of drugs is at the treating physician's discretion (for example, intravenous fibrinolysis, anticoagulants, or antiplatelet agents) according to the local standards of care, but not intra-arterial therapies. | Procedure or surgery | Endovascular treatment + best medical treatment |
| Best medical treatment (BMT)Administration of drugs is at the treating physician's discretion (for example, intravenous fibrinolysis, anticoagulants, or antiplatelet agents) according to the local standards of care, but not intra-arterial therapies. | Procedure or surgery | best medical treatment |
Primary outcome
Percentage of patients with favorable functional outcome, defined by a mRS score ≤2
Time frame: Day 90 (± 15 days) post-randomization
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.The scale runs from "0" to "6", running from perfect health without symptoms to death. The mRS score will be evaluated by qualified assessors blinded to the initial treatment.The blinded evaluator must be familiar with mRS scoring (dedicated training and certification). If a participant is unable to attend in-person the follow-up visit at day 90 (±15), mRS scoring can be done by telephone by a qualified investigator.
18 secondary outcomes
The degree of disability at day 90 (±15) post-randomization (shift on the mRS combining scores of 5 and 6)
Time frame: Day 90 (± 15 days) post-randomization
Change in NIHSS score at 24 (-6/+12) hours post-randomization.
Time frame: 24h (-6/+12) post-randomization
Quality of life at day 90 (±15) post-randomization assessed with the EuroQol 5D-5L
Time frame: Day 90 (± 15 days) post-randomization
Cognitive function at day 90 (±15) post-randomization, evaluated with the Montreal Cognitive assessment (MoCA test).
Time frame: Day 90 (±15 days) post randomization
Carotid artery revascularization rate
Time frame: randomization
Carotid artery recanalization rate
Time frame: 24 (-6/+12) hours post randomization
Carotid artery recanalization rate
Time frame: Day 90 (± 15 days) post-randomization
Infarct volume
Time frame: 24 (-6/+12) hours post randomization
Infarct volume
Time frame: Day 90 (± 15 days) post randomization
Early neurological improvement
Time frame: Day 0 - 24 hours post randomization
Incidence of all-cause mortality at day 90
Time frame: Day 90 (± 15 days) post randomization
Rate of symptomatic intracranial hemorrhage
Time frame: 24 (-6/+12) hours post-randomization
Incidence of procedure/device-related adverse events
Time frame: Day 30 (±5 days) post randomization
Early neurological deterioration rate
Time frame: 24 hours post-randomization
Neurological deterioration rate
Time frame: Day 5-7 post randomization
Rapid NIHSS worsening
Time frame: Admission - day 5/day 7/discharge (if earlier)
Degree of disability at day 30 post-randomization (shift on the mRS combining scores of 5 and 6)
Time frame: Day 30 (±5 days) post randomization
Incidence of symptomatic intracranial hemorrhage according to the SITS-MOST
Time frame: Day 90 (±15 days) post randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular treatment (EVT) + Best medical treatment (BMT) and Best medical treatment (BMT) in people with Acute Ischemic Stroke, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline ARQUIZAN, Medical Doctor (0033467330204, c-arquizan@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with favorable functional outcome, defined by a mRS score ≤2 (time frame: Day 90 (± 15 days) post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.