Informations générales (source: ClinicalTrials.gov)
Evaluation of Acute Mechanical Revascularization in Large Vessel Occlusion Stroke With Minor Symptoms (NIHSS<6) in Patients Last Seen Well < 24 Hours (MOSTE)
Interventional
N/A
University Hospital, Montpellier (Voir sur ClinicalTrials)
avril 2019
octobre 2025
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | BERTRAND LAPERGUE | 05/05/2025 07:12:02 | Contacter | ||
| HOPITAL FONDATION A. DE ROTHSCHILD | Michel PIOTIN | 21/06/2024 13:33:12 | Contacter | ||
Critères
Tous
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.
- 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.
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