Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Best Medical Therapy (BMT) | Other | Best treatment medical probably associated to the rescue endovascular treatment in case of neurological deterioration |
|
| Mechanical Thrombectomy (MT) | Other | Endovascular treatment (thrombectomy) associated with the best treatment medical |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Medical Therapy | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of all-cause mortality at 90 days | Evaluation of mortality at 90 days | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of symptomatic intracerebral hemorrhage | Incidence of symptomatic intracerebral hemorrhage according to HEIDELBERG at imaging at 24 (-6/+12) hours post randomization | 1 day |
| Deterioration of patient's condition |
Not provided
Inclusion Criteria:
Exclusion Criteria:
General Exclusion Criteria
Imaging Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline ARQUIZAN, PH | Contact | 4 67 33 75 32 | +33 | c-arquizan@chu-montpellier.fr |
| Bertrand LAPERGUE, PH | Contact | 1 46255973 | +33 | bertrand.lapergue@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Vincent COSTALAT, PU-PH | Hôpital Gui de Chauliac | Principal Investigator |
| Caroline ARQUIZAN, PH | Hôpital Gui de Chauliac | Principal Investigator |
| Bertrand LAPERGUE, PH |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Gui De Chauliac | Recruiting | Montpellier | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37526012 | Derived | 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. | |
| 37350574 | Derived | Arquizan 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Mechanical Thrombectomy | Procedure | 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 |
|
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 |
| 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 |
| 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 |
| 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 |
| Evaluation of cognitive function | Cognitive function at 90-days according to Montreal Cognitive Assessment (MoCA) | 3 months |
| Evaluation of cognitive function | Cognitive function at 90-days according to Trail Making Test A and B | 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 | 3 months |
| Evaluation of functional outcome | Rate of patients at 90-days with excellent outcome defined as Modified Rankin Scale (mRS) 0-1 | 3 months |
| Hôpital Foch |
| Principal Investigator |
| Tudor JOVIN, PU-PH | Cooper Neurological Institute | Principal Investigator |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |