StrokeMOSTENCT03796468
Minor Stroke Therapy Evaluation
A study testing Best Medical Therapy and Mechanical Thrombectomy in people with Stroke, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke
- What is being tested?
- Best Medical Therapy and Mechanical Thrombectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 824 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2019to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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))
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- 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.
Who cannot join
- 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.
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Gui De Chauliac
Montpellier, 34295
Caroline ARQUIZAN, MD, 4 67 33 75 32 ext. +33, c-arquizan@chu-montpellier.fr
Vincent COSTALAT, PU-PH, 4 67 33 75 32, v-costalat@chu-montpellier.fr
About this study
Official 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Best Medical Therapy, Mechanical Thrombectomy
- Keywords
- Mechanical thrombectomy, stroke, Proximal intracranial arterial occlusions, Large vessel occlusion
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best Medical TherapyOther
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
Mechanical ThrombectomyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Best Medical Therapy (BMT) | Other | Best treatment medical probably associated to the rescue endovascular treatment in case of neurological deterioration Receives: Other: Best Medical Therapy |
| Mechanical Thrombectomy (MT) | Other | Endovascular treatment (thrombectomy) associated with the best treatment medical Receives: Procedure: Mechanical Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all-cause mortality at 90 days
Evaluation of mortality at 90 days
Measured: 3 months
Secondary outcomes (9)
Incidence of symptomatic intracerebral hemorrhage
Incidence of symptomatic intracerebral hemorrhage according to HEIDELBERG at imaging at 24 (-6/+12) hours post randomization
Measured: 1 day
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.
Measured: 3 months
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)
Measured: 1 day
Evaluation of functional outcome
Rate of patients with a favorable or perfect outcome at 90-days defined by mRS 0-2 or mRS 0
Measured: 3 months
Quality of life of the patient
Quality of life at 90 days assessed by EuroQol 5D-5L (5-level EQ-5-Dimension) scale
Measured: 3 months
Evaluation of cognitive function
Cognitive function at 90-days according to Montreal Cognitive Assessment (MoCA)
Measured: 3 months
Evaluation of cognitive function
Cognitive function at 90-days according to Trail Making Test A and B
Measured: 3 months
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
Measured: 3 months
Evaluation of functional outcome
Rate of patients at 90-days with excellent outcome defined as Modified Rankin Scale (mRS) 0-1
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start10 Apr 2019
- Primary completionJul 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 824 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent COSTALAT, PU-PH, Principal investigator, Hôpital Gui de ChauliacCaroline ARQUIZAN, PH, Principal investigator, Hôpital Gui de ChauliacBertrand LAPERGUE, PH, Principal investigator, Hôpital FochTudor JOVIN, PU-PH, Principal investigator, Cooper Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796468
- Sponsor's protocol ID
- RECHMPL18_0172
- Acronym
- MOSTE
- Status last verified
- Aug 2023
- First submitted
- 2 Jan 2019
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Seners P, Cereda CW. Thrombectomy in Stroke With a Large Vessel Occlusion and Mild Symptoms: "Striving to Better, Oft We Mar What's Well?". Stroke. 2023 Sep;54(9):2276-2278. doi: 10.1161/STROKEAHA.123.044205. Epub 2023 Aug 1. No abstract available.
PubMed 37526012Arquizan C, Lapergue B, Gory B, Labreuche J, Henon H, Albucher JF, Sibon I, Turc G, Richard S, Nouri N, Cognard C, Marnat G, Naggara O, Di Maria F, Duhamel A, Jovin T, Costalat V; MOSTE Trial Investigators. Evaluation of acute mechanical revascularization in minor stroke (NIHSS score ⩽ 5) and large vessel occlusion: The MOSTE multicenter, randomized, clinical trial protocol. Int J Stroke. 2023 Dec;18(10):1255-1259. doi: 10.1177/17474930231186039. Epub 2023 Jul 16.
PubMed 37350574
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Acute Mechanical Revascularization in Large Vessel Occlusion Stroke With Minor Symptoms (NIHSS<6) in Patients Last Seen Well < 24 Hours
- ClinicalTrials.gov ID
- NCT03796468
- Acronym / sponsor ID
- MOSTE / RECHMPL18_0172
- Conditions
- Stroke
- Keywords
- Mechanical thrombectomy, stroke, Proximal intracranial arterial occlusions, Large vessel occlusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 824 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 8 Jan 2019 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best Medical Therapy (BMT) | Other | Other: Best Medical TherapyBest treatment medical probably associated to the rescue endovascular treatment in case of neurological deterioration |
| Mechanical Thrombectomy (MT) | Other | Procedure: Mechanical ThrombectomyEndovascular treatment (thrombectomy) associated with the best treatment medical |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (22 listed)
- 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
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 |
|---|---|---|
| Best Medical TherapyThe 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 | Other | Best Medical Therapy (BMT) |
| Mechanical ThrombectomyMT 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 | Procedure or surgery | Mechanical Thrombectomy (MT) |
Primary outcome
Incidence of all-cause mortality at 90 days
Time frame: 3 months
Evaluation of mortality at 90 days
9 secondary outcomes
Incidence of symptomatic intracerebral hemorrhage
Time frame: 1 day
Deterioration of patient's condition
Time frame: 3 months
Incidence of procedure/device-related adverse events
Time frame: 1 day
Evaluation of functional outcome
Time frame: 3 months
Quality of life of the patient
Time frame: 3 months
Evaluation of cognitive function
Time frame: 3 months
Evaluation of cognitive function
Time frame: 3 months
Medico-economic study
Time frame: 3 months
Evaluation of functional outcome
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Derived from this study: PubMed 37526012Seners P, Cereda CW. Thrombectomy in Stroke With a Large Vessel Occlusion and Mild Symptoms: "Striving to Better, Oft We Mar What's Well?". Stroke. 2023 Sep;54(9):2276-2278. doi: 10.1161/STROKEAHA.123.044205. Epub 2023 Aug 1. No abstract available.
- Derived from this study: PubMed 37350574Arquizan C, Lapergue B, Gory B, Labreuche J, Henon H, Albucher JF, Sibon I, Turc G, Richard S, Nouri N, Cognard C, Marnat G, Naggara O, Di Maria F, Duhamel A, Jovin T, Costalat V; MOSTE Trial Investigators. Evaluation of acute mechanical revascularization in minor stroke (NIHSS score ⩽ 5) and large vessel occlusion: The MOSTE multicenter, randomized, clinical trial protocol. Int J Stroke. 2023 Dec;18(10):1255-1259. doi: 10.1177/17474930231186039. Epub 2023 Jul 16.
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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. This study is not recruiting at the moment.
Vincent COSTALAT, PU-PH principal investigator
Hôpital Gui de Chauliac
Caroline ARQUIZAN, PH principal investigator
Hôpital Gui de Chauliac
Bertrand LAPERGUE, PH principal investigator
Hôpital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Medical Therapy and Mechanical Thrombectomy in people with 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 10 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 31 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline ARQUIZAN, PH (4 67 33 75 32 ext. +33, 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?
Incidence of all-cause mortality at 90 days (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03796468, which also lists 2 linked publications.
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 31 Aug 2023.