Large cerebral infarctions are frequent and associated with a poor outcome. Previous cohort studies results suggest that patients with an acute ischemic stroke with large core and substantial penumbra on perfusion imaging benefit from EVT while those with no salvageable ischemic tissue did not. The Investigator aim to demonstrate in a randomized controlled trials (RCT) that EVT (Endo Vascular Treatment) in addition to BMT (Best Medical Treatment) increases the rate of functional recovery (mRS 0-2) at 3 months in patients with a LVO-related AIS with a large core and substantial penumbra evolving for less than 24hrs
The reperfusion of salvageable ischemic tissue (penumbra) to improve functional recovery is the aim of the endovascular treatment (EVT) of acute ischemic stroke (AIS) complicating large cerebral vessel occlusion (LVO). Downstream of an LVO, imaging profiles are highly variable ranging from a large completed infarction within 2 hrs to a small core and a large mismatch at 24 hrs after onset . A large core is typically associated with a poor prognosis and was a common exclusion criterion from the RCTs that demonstrated the efficacy of EVT for LVO related AIS . However the investigator recently reported that AIS with a large core 1- represent 20% of the LVO-related AIS scanned within 6 hours after onset 2- Up to 50% had a MM on perfusion imaging and 3- EVT increases the rate of functional recovery in patients with a large core over BMT only in the subgroup of patients with a MM (Mismatch) on baseline imaging . One hundred and eighty patients experiencing an LVO-related AIS within 24 hours after last known well, with a documented large core (\>70mL) and a MM on baseline imaging will be randomized (1:1) to undergo EVT+BMT vs. BMT in a multicenter, randomized, controlled, open-label, in parallel groups with blinded endpoint evaluation (PROBE design) superiority trial. Study participants will be followed up for 6 months. Participants will be treated and managed in acute stroke units by certified stroke neurologists and neurointerventionists according to the current recommendations . Neurological deficit will be assessed using the NIH Stroke Scale (NIHSS) by certified investigators.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2
Endovascular treatment (EVT) of acute ischemic stroke (AIS) related to an anterior large cerebral vessel occlusion (LVO)
Hôpital Pellegrin
Bordeaux, France
University Hospital of Lille Hôpital Roger Salengro
Lille, France
University Hospital of Limoges Hôpital Dupuytren 1
Limoges, France
University Hospital of Montpellier Hôpital Gui de Chauliac
Montpellier, France
University Hospital of Nancy (CHRU) Hôpital central
Nancy, France
Fondation Adolphe de Rothschild Hospital
Paris, France
University Hospital Pitié-Salpétrière AP-HP
Paris, France
Foch Hospital Centre
Suresnes, France
University Hospital Toulouse
Toulouse, France
Rate of patients achieving a functional recovery defined by modified Rankin Scale 0-2 at 3 months
Good functional outcome will be defined by a Modified Rankin Scale of 0-2, done by a certified rater, blinded of the arm of the randomization
Time frame: 3 months
modified Rankin Scale
Rate of patients with Modified Rankin Scale of 0-2 , rate of patients with Modified Rankin Scale 0-3 and Global disability assessed by overall distribution of the Modified Rankin Scale (shift analysis combining scores 5 and 6)
Time frame: 3 and 6 months
National Institute of Health Scale
Rate of patients achieving an early neurological improvement National Institutes of Health Stroke Scale (NIHSS) \>or=8 reduction from baseline to day 1 or National Institutes of Health Stroke Scale (NIHSS) =0-1 at day 1
Time frame: Day 1
Modified Thrombolysis in Cerebral Infarction score
Rate of successful reperfusion in the EndoVascular Treatment+Best medical treatment arm defined by a mTICI ( Modified Thrombolysis in Cerebral Infarction) 2bc3 score
Time frame: Day 1
mortality rate
Number of subject who die during the study participation in each arm.
Time frame: 3 and 6 months
Symptomatic Hemorrhagic Transformation
Symptomatic hemorrhagic transformation is defined by an intra cerebral hemorrhage (European Cooperative Acute Stroke Study III classification " ECASS III ") associated with a 4 or more point increase on the National Institute of Health " NIH " Stroke Scale by comparison with NIH Stroke Scale immediately predeterioration.
Time frame: 36 hours
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