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Treatment of acute ischemic stroke due to occlusion of a large vessel by mechanical thrombectomy in patients with unknown onset or not meeting the criteria for CT eligibility (ASPECTS <6) based on MRI criteria (DWIFLAIR mismatch)
EU CTIS ID: 2024-515062-13-00
What this study is testing
The main objective of this study is to assess whether the mechanical thrombectomy added to standard treatment including acetylsalicylic acid is superior to standard treatment alone including acetylsalicylic acid, in patients with acute ischemic stroke due to large vessel occlusion and initial neurological deficit NIHSS ≥ 5, using functional outcome score with modified Rankin Scale, that includes patient mortality, after 90 days.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Obtaining informed consent to participate in the trial prior to randomization. NOTE: Patients whose severe neurological deficit makes it impossible to sign the consent form may give their verbal consent to participate in the study. This consent should be additionally confirmed by the signature of an independent witness who is not a family member of the patient and does not participate in the study. Patients with aphasia and / or other speech disorders may be enrolled in the study if, in the opinion of the recruiting neurologist or neurologist in training, they are able to understand the study concept.
- Adult patients with acute ischemic stroke due to the occlusion of a large intracranial or extracranial vessel (angio-CT or angio-MR) in a place that allows mechanical recanalization using a stent-retriever.
- Current DWI-FLAIR mismatch. In the WAKE-IN study, a DWI-FLAIR mismatch is defined as: No hyperintense change in the FLAIR sequence corresponding to acute ischemia in DWI or the ratio of the volume of restriction of diffusion in the DWI sequence (hyperintensive lesion) to the corresponding hyperintense lesion volume in the FLAIR sequence 1.5 or higher. Note: The presence of other changes in the FLAIR sequence, such as "chronic" white matter lesions, do not exclude from participation in the study.
- The neurological deficit was assessed at 5-18 points on the NIHSS scale.
- Age>18 years of age.
- Arm A: 1.Unknown time of onset (not more than 24 hours from when the patient was symptom-free), or the time from onset to estimated arterial puncture between 6 and 24 hours.
You likely can't join if
- Significant disability prior to the current event defined as > 2 points on the modified Rankin Scale (mRS) and/or significant cognitive impairment prior to the current event (documented in the patient's medical records).
- Intracranial bleeding in neuroimaging (CT or MRI of the brain).
- Neuroimaging pathologies other than ischemia-related pathologies that may be responsible for acute symptoms.
- Significant pathologies detected accidentally in neuroimaging (e.g. tumor, giant aneurysm, massive brain atrophy).
- Clinical suspicion of subarachnoid bleeding (even if the CT or MRI result is normal).
- Clinical suspicion of cerebral venous sinus thrombosis.
See the full eligibility criteria
Who can join
- Obtaining informed consent to participate in the trial prior to randomization. NOTE: Patients whose severe neurological deficit makes it impossible to sign the consent form may give their verbal consent to participate in the study. This consent should be additionally confirmed by the signature of an independent witness who is not a family member of the patient and does not participate in the study. Patients with aphasia and / or other speech disorders may be enrolled in the study if, in the opinion of the recruiting neurologist or neurologist in training, they are able to understand the study concept.
- Adult patients with acute ischemic stroke due to the occlusion of a large intracranial or extracranial vessel (angio-CT or angio-MR) in a place that allows mechanical recanalization using a stent-retriever.
- Current DWI-FLAIR mismatch. In the WAKE-IN study, a DWI-FLAIR mismatch is defined as: No hyperintense change in the FLAIR sequence corresponding to acute ischemia in DWI or the ratio of the volume of restriction of diffusion in the DWI sequence (hyperintensive lesion) to the corresponding hyperintense lesion volume in the FLAIR sequence 1.5 or higher. Note: The presence of other changes in the FLAIR sequence, such as "chronic" white matter lesions, do not exclude from participation in the study.
- The neurological deficit was assessed at 5-18 points on the NIHSS scale.
- Age>18 years of age.
- Arm A: 1.Unknown time of onset (not more than 24 hours from when the patient was symptom-free), or the time from onset to estimated arterial puncture between 6 and 24 hours.
- Arm A: 2. Failure to meet the DAWN and DEFUSE-3 eligibility criteria.
- Arm B: 1.From 0 to 5 points on the ASPECTS scale.
- Arm B: 2. Time from the first symptoms of acute stroke to arterial puncture not exceeding 6 hours.
What rules you out
- Significant disability prior to the current event defined as > 2 points on the modified Rankin Scale (mRS) and/or significant cognitive impairment prior to the current event (documented in the patient's medical records).
- Intracranial bleeding in neuroimaging (CT or MRI of the brain).
- Neuroimaging pathologies other than ischemia-related pathologies that may be responsible for acute symptoms.
- Significant pathologies detected accidentally in neuroimaging (e.g. tumor, giant aneurysm, massive brain atrophy).
- Clinical suspicion of subarachnoid bleeding (even if the CT or MRI result is normal).
- Clinical suspicion of cerebral venous sinus thrombosis.
- Previous or chronic disease of the central nervous system that significantly impairs the functional state and/or has a poor prognosis (brain tumors, aneurysms, arteriovenous malformations, open brain surgery with dura mater/dural incision).
- Infective endocarditis or pericarditis.
- Very high blood pressure, i.e. systolic blood pressure>185 mm Hg or diastolic blood pressure >110 mm Hg immediately before the intervention. NOTE: If pharmacological intervention (e.g., bolus administration of labetalol or urapidil, or in the absence of a satisfactory continuous infusion response via an infusion pump) has produced a satisfactory response (blood pressure <185/110 mmHg) prior to randomization and / or initiation of treatment and in the opinion of the physician, adequate blood pressure control can be maintained throughout the course of treatment, the patient will be enrolled in the study.
- Pregnancy or breast-feeding.
- Life expectancy <3 months, participation in another clinical trial at the time of randomization or planned enrollment in another clinical trial within less than 30 days from randomization, provided that there is pathophysiological or formal-administrative interference in the protocols of these studies.
- Known heart failure (if medical history available) with EF <25%; in the absence of information without the need for testing at the randomization stage.
- Acute pancreatitis.
- Severe renal failure (eGFR <30 ml / min / 1.73 m2).
- Suspected systemic vasculitis or primary central nervous system vasculitis.
- Severe liver disease, including liver failure, cirrhosis, or portal hypertension.
- Platelet count <100,000/mm3.
- Glucose concentration <50 mg/dl (2.8 mmol/l) or >400 mg/dl (22.2 mmol/l) immediately before the intervention.
- MRI contraindications or inability to identify contraindications.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.