Back to resultsMinor Stroke Therapy Evaluation (MOSTE)
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Best Medical Therapy
Mechanical Thrombectomy
Sponsored by
About this trial
This is an interventional other trial for Stroke focused on measuring Mechanical thrombectomy, stroke, Proximal intracranial arterial occlusions, Large vessel occlusion
Eligibility Criteria
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
Sites / Locations
- Hopital Gui De ChauliacRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Best Medical Therapy (BMT)
Mechanical Thrombectomy (MT)
Arm Description
Best treatment medical probably associated to the rescue endovascular treatment in case of neurological deterioration
Endovascular treatment (thrombectomy) associated with the best treatment medical
Outcomes
Primary Outcome Measures
Incidence of all-cause mortality at 90 days
Evaluation of mortality at 90 days
Secondary Outcome Measures
Incidence of symptomatic intracerebral hemorrhage
Incidence of symptomatic intracerebral hemorrhage according to HEIDELBERG at imaging at 24 (-6/+12) hours post randomization
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.
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)
Evaluation of functional outcome
Rate of patients with a favorable or perfect outcome at 90-days defined by mRS 0-2 or mRS 0
Quality of life of the patient
Quality of life at 90 days assessed by EuroQol 5D-5L (5-level EQ-5-Dimension) scale
Evaluation of cognitive function
Cognitive function at 90-days according to Montreal Cognitive Assessment (MoCA)
Evaluation of cognitive function
Cognitive function at 90-days according to Trail Making Test A and B
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
Evaluation of functional outcome
Rate of patients at 90-days with excellent outcome defined as Modified Rankin Scale (mRS) 0-1
Full Information
NCT ID
NCT03796468
First Posted
January 2, 2019
Last Updated
August 30, 2023
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT03796468
Brief Title
Minor Stroke Therapy Evaluation
Acronym
MOSTE
Official Title
Evaluation of Acute Mechanical Revascularization in Large Vessel Occlusion Stroke With Minor Symptoms (NIHSS<6) in Patients Last Seen Well < 24 Hours
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
Proximal intracranial arterial occlusions cause the most disabling types of ischemic strokes and are predictive of poor neurological outcomes. The "Time is Brain" assessment has been confirmed in many recent trials (MR CLEAN, SWIFT PRIME, REVASCAT, HERMES) within the first 6 hours. Recently the time window has been enlarged to 24h00 after the DAWN trial results, enforcing nevertheless the strong relation between patient disability and time loss in this extended time window.
In population-based studies, patients presenting with minor or mild stroke symptoms represent about two-thirds of stroke patients, and almost one-third of these patients are unable to ambulate independently at the time of discharge.
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. Indeed, the majority of patients presented with major clinical impairment, with a median NIHSS of 17. Thus, American Heart Association (AHA) gives level 1a evidence for MT performed only for patients with baseline NIHSS score ≥6.
However, patients with proximal occlusions may present with a low NIHSS, a proximal intra-arterial occlusion being present in up to 28% when considering patients with an NIHSS ≤ 4. In observational study, patient with minor or mild stroke symptoms and LVO have a high risk of both clinical worsening and bad outcome.
The STAIR meeting aims to advance acute stroke therapy development through collaboration between academia, industry, and regulatory institutions. In pursuit of this goal and building on the available level I evidence of benefit from endovascular therapy (EVT) in large vessel occlusion stroke, STAIR IX consensus recommendations were developed that outline priorities for future research in EVT.
Recent AHA/ASA guidelines have also highlighted the need to gain more evidence to determine whether there is an overall net benefit from endovascular therapy (EVT) in patients with LVO and minor stroke.
The MOSTE protocol is an International, multi-center, prospectively randomized to two parallel (1:1) arms, open to treatment with blinded endpoint trial, designed to demonstrate that mechanical thrombectomy with best medical treatment is superior to medical treatment alone, in improving clinical outcomes at 90 days, in patient presenting an acute large vessel occlusion stroke with a minor deficit, defined as NIHSS below 6 and < 24 hours from onset. If this study is positive, more patients in the future could receive urgent endovascular treatment in addition to the best medical treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Mechanical thrombectomy, stroke, Proximal intracranial arterial occlusions, Large vessel occlusion
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
824 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Best Medical Therapy (BMT)
Arm Type
Other
Arm Description
Best treatment medical probably associated to the rescue endovascular treatment in case of neurological deterioration
Arm Title
Mechanical Thrombectomy (MT)
Arm Type
Other
Arm Description
Endovascular treatment (thrombectomy) associated with the best treatment medical
Intervention Type
Other
Intervention Name(s)
Best Medical Therapy
Intervention Description
The administration of medications is at the treating physician's discretion (for example intravenous fibrinolysis, anticoagulants or antiplatelet) according to local standards of care but may NOT include any intra-arterial therapies. The rescue MT may be performed in case of deterioration within the 24 hours
Intervention Type
Procedure
Intervention Name(s)
Mechanical Thrombectomy
Intervention Description
MT in the Experimental Arm can be performed with any thrombectomy (CE labeled) device usually used at study site. For the subjects randomized to the MT plus medical, the MT is performed immediately after the randomization
Primary Outcome Measure Information:
Title
Incidence of all-cause mortality at 90 days
Description
Evaluation of mortality at 90 days
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Incidence of symptomatic intracerebral hemorrhage
Description
Incidence of symptomatic intracerebral hemorrhage according to HEIDELBERG at imaging at 24 (-6/+12) hours post randomization
Time Frame
1 day
Title
Deterioration of patient's condition
Description
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.
Time Frame
3 months
Title
Incidence of procedure/device-related adverse events
Description
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)
Time Frame
1 day
Title
Evaluation of functional outcome
Description
Rate of patients with a favorable or perfect outcome at 90-days defined by mRS 0-2 or mRS 0
Time Frame
3 months
Title
Quality of life of the patient
Description
Quality of life at 90 days assessed by EuroQol 5D-5L (5-level EQ-5-Dimension) scale
Time Frame
3 months
Title
Evaluation of cognitive function
Description
Cognitive function at 90-days according to Montreal Cognitive Assessment (MoCA)
Time Frame
3 months
Title
Evaluation of cognitive function
Description
Cognitive function at 90-days according to Trail Making Test A and B
Time Frame
3 months
Title
Medico-economic study
Description
Cost-effectiveness analysis (number of patients functionally independent at 3 months : mRS =< 2), cost of devices and drugs, staff hourly cost, operating room cost
Time Frame
3 months
Title
Evaluation of functional outcome
Description
Rate of patients at 90-days with excellent outcome defined as Modified Rankin Scale (mRS) 0-1
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline ARQUIZAN, PH
Phone
4 67 33 75 32
Ext
+33
Email
c-arquizan@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Bertrand LAPERGUE, PH
Phone
1 46255973
Ext
+33
Email
bertrand.lapergue@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent COSTALAT, PU-PH
Organizational Affiliation
Hôpital Gui de Chauliac
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Caroline ARQUIZAN, PH
Organizational Affiliation
Hôpital Gui de Chauliac
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bertrand LAPERGUE, PH
Organizational Affiliation
Hôpital Foch
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tudor JOVIN, PU-PH
Organizational Affiliation
Cooper Neurological Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Gui De Chauliac
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline ARQUIZAN, MD
Phone
4 67 33 75 32
Ext
+33
Email
c-arquizan@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Vincent COSTALAT, PU-PH
Phone
4 67 33 75 32
Email
v-costalat@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Bertrand LAPERGUE, MD
First Name & Middle Initial & Last Name & Degree
Tudor JOVIN, MD
12. IPD Sharing Statement
Learn more about this trial
Minor Stroke Therapy Evaluation
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