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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular treatment + best medical treatment | Experimental | Endovascular treatment associated with the best medical treatment. |
|
| best medical treatment | Active Comparator | Best medical treatment alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular treatment (EVT) + Best medical treatment (BMT) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 90 (± 15 days) post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline ARQUIZAN, Medical Doctor | Contact | 0033467330204 | c-arquizan@chu-montpellier.fr | |
| COSTALAT Vincent, Medical Doctor | Contact | 0033467337532 | v-costalat@chu-montpellier.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology/ Stroke Unit, Hôpital Gui de Chauliac | Recruiting | Montpellier | Fance | France |
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The protocol is a national, multi-center, prospectively randomized into two parallel (1:1) arms, open to treatment with blinded endpoint trial (PROBE)
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As the therapeutic arm is interventional in the experimental arm, the physicians in charge of the patient and the patients cannot be blinded.
The mRS score will be evaluated by qualified assessors blinded to the initial treatment
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| Best medical treatment (BMT) | Procedure | 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. |
|
| 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. | 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. | 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. | 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% | randomization |
| Carotid artery recanalization rate | Assessed by MRA with gadolinium or CTA, defined as complete recanalization or residual carotid artery stenosis <50% | 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% | Day 90 (± 15 days) post-randomization |
| Infarct volume | Measured by magnetic resonance angiography (MRI, FLAIR) or computed tomography (CT). | 24 (-6/+12) hours post randomization |
| Infarct volume | Measured by magnetic resonance angiography (MRI, FLAIR) or computed tomography (CT). | 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. | Day 0 - 24 hours post randomization |
| Incidence of all-cause mortality at day 90 | Incidence of all-cause mortality at day 90 | Day 90 (± 15 days) post randomization |
| Rate of symptomatic intracranial hemorrhage | According to the Heidelberg Bleeding classification by cerebral imaging | 24 (-6/+12) hours post-randomization |
| Incidence of procedure/device-related adverse events | In the experimental group (EVT + BMT) | Day 30 (±5 days) post randomization |
| Early neurological deterioration rate | NIHSS score increase by ≥4 points | 24 hours post-randomization |
| Neurological deterioration rate | NIHSS score increase by ≥4 points | Day 5-7 post randomization |
| Rapid NIHSS worsening | NIHSS score increase by ≥10 points | 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. | Day 30 (±5 days) post randomization |
| Incidence of symptomatic intracranial hemorrhage according to the SITS-MOST | Day 90 (±15 days) post randomization |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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