Stroke Clinical Trial
— MOSTEOfficial title:
Evaluation of Acute Mechanical Revascularization in Large Vessel Occlusion Stroke With Minor Symptoms (NIHSS<6) in Patients Last Seen Well < 24 Hours
Stroke represents the fourth leading cause of death in industrialized nations, after heart disease, cancer, and chronic lower respiratory disease. Approximately one-quarter of the patients suffering a stroke die within one year after the initial event and stroke is a leading cause of serious long-term disability. Although mechanical thrombectomy (MT) has become the standard of care for acute ischemic stroke with proximal large vessel occlusion (LVO) in the anterior circulation, the management of patients harboring proximal occlusion but presenting minor-to-mild stroke symptoms, has not yet been determined by these recent randomized clinical trials. However, patients with proximal occlusions may present with a low NIHSS, a proximal intraarterial occlusion being present in up to 28% when considering patients with an NIHSS ≤ 4. The evidence of benefit from endovascular therapy (EVT) in large vessel occlusion stroke is demonstrated, STAIR IX (Stroke Treatment Academic Industry Roundtable) consensus recommendations were developed that outline priorities for future research in EVT.
Status | Recruiting |
Enrollment | 824 |
Est. completion date | October 2025 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Subject is = 18 years old at inclusion (no upper age limit) - Clinical signs consistent with acute ischemic stroke with time last known well (TLKW) = 23h at randomization (With the goal of remaining within 24 hours from TLKW til treatment) - Patients NIHSS 0-5 at the time of randomization - ASPECT = 6 on non-contrast CT or Diffusion Weighted Imaging (DWI)-MRI - Ischemic Stroke confirmed with cerebral imaging or normal imaging with suspected ischemic stroke - Proved anterior circulation intracranial large vessel occlusion on CTA or Magnetic resonance angiography (MRA) (ICA, M1, M1-M2, with or without cervical lesion (Tandem)) - Patient or patient's representative has received information about the study and has signed and dated the appropriate Informed Consent Form, or fulfilling the criteria for emergent consent. - Anticipated possibility to start the procedure (arterial access) within 60 minutes after randomization - Pre stroke mRS = 1 - For Drip and Ship patients : new imaging performed again on inclusion center if first imaging performed > 1 hour before randomization. Exclusion Criteria: General Exclusion Criteria - Anticipated impossibility to start the procedure (arterial access) within 60 minutes after randomization - Known absence of vascular access - Known contrast or endovascular product life-threatening allergy - Female who is known to be pregnant or lactating at time of admission - Patient presents severe or fatal co-morbidities or Life expectancy under 6 months that will likely prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient. - Patient unable to present or be available for follow-up - Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations - Evidence of vessel recanalization prior to randomization - Seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment. - Current participation in another investigational drug study - Suspicion of aortic dissection based on medical history, clinical evaluation or/and imaging - Major patients under guardianship Imaging Exclusion Criteria - Evidence of intracranial hemorrhage on CT/MRI - Excessive tortuosity of cervical vessels on CTA/MRA that would likely result in unstable access platform - High Suspicion of underlying intracranial stenosis on CTA/MRA - Suspected cerebral vascular disease (e.g. vasculitis) based on medical history and CTA/MRA - Presumed calcified Embolus or Intracranial Stenosis decompensation - Intracranial stent implanted in the same vascular territory that would preclude the safe deployment/removal of the stentriever device - Occlusions in multiple vascular territories (e.g.: bilateral anterior circulation, or anterior circulation/vertebrobasilar system) on CTA/MRA - Significant mass effect with midline shift as confirmed on CT/MRI |
Country | Name | City | State |
---|---|---|---|
France | Hopital Gui De Chauliac | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of all-cause mortality at 90 days | Evaluation of mortality at 90 days | 3 months | |
Secondary | Incidence of symptomatic intracerebral hemorrhage | Incidence of symptomatic intracerebral hemorrhage according to HEIDELBERG at imaging at 24 (-6/+12) hours post randomization | 1 day | |
Secondary | Deterioration of patient's condition | National Intitutes of Health Stroke Scale (NIHSS) = 10 points during hospitalization. this scale is constitued by 15 items and the minimum score is 1 and the maximum score is 20. | 3 months | |
Secondary | Incidence of procedure/device-related adverse events | Incidence of procedure/device-related adverse events (in patients treated by mechanical treatment, in the MT group or in the BMT group, in case of rescue therapy) | 1 day | |
Secondary | Evaluation of functional outcome | Rate of patients with a favorable or perfect outcome at 90-days defined by mRS 0-2 or mRS 0 | 3 months | |
Secondary | Quality of life of the patient | Quality of life at 90 days assessed by EuroQol 5D-5L (5-level EQ-5-Dimension) scale | 3 months | |
Secondary | Evaluation of cognitive function | Cognitive function at 90-days according to Montreal Cognitive Assessment (MoCA) | 3 months | |
Secondary | Evaluation of cognitive function | Cognitive function at 90-days according to Trail Making Test A and B | 3 months | |
Secondary | Medico-economic study | Cost-effectiveness analysis (number of patients functionally independent at 3 months : mRS =< 2), cost of devices and drugs, staff hourly cost, operating room cost | 3 months | |
Secondary | Evaluation of functional outcome | Rate of patients at 90-days with excellent outcome defined as Modified Rankin Scale (mRS) 0-1 | 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Suspended |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Enrolling by invitation |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Active, not recruiting |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Recruiting |
NCT05621980 -
Finger Movement Training After Stroke
|
N/A |