To evaluate the hypothesis that mechanical embolectomy with the Solitaire FR device is superior to medical management alone in achieving favorable outcome in the distribution of the modified Rankin Scale scores at 90 days in subjects presenting with acute large vessel ischemic stroke \< 8 hours from symptom onset.
Prospective, multi-center, randomized, controlled, open, blinded-endpoint trial with a sequential design. The randomization employs a 1:1 ratio of mechanical embolectomy with the CE MARK approved stentriever Solitaire FR® versus medical management alone. Randomization will be done under a minimization process using age, baseline NIHSS, therapeutic window and vessel occlusion site. For the primary endpoint, subjects will be followed for 90 days post-randomization. Interim analysis will be performed as preplanned and interpreted by the Data Safety Monitoring Board (DSMB) after the first 174, 346 and 518 patients representing 25%, 50% and 75% of the planned sample size have completed their 90-day follow-up. The DSMB will advise the executive committee (EC) on recommendations to stop the trial early either for reasons of safety, efficacy, futility or to adjust the sample size. The latter may be necessary as given the paucity of data regarding natural history of the non-treated patients assumptions regarding rates of favorable outcomes in this group of patients may be incorrect. Of note, sample size adjustment based on different than expected outcomes rates is permitted, but it is not permitted to adjust the sample size based on change in the pre-specified treatment effect which is set at 10%. Subject population: Subjects presenting with acute ischemic stroke within 8 hours from symptom onset and whose strokes are attributable to an occlusion of the internal carotid or proximal MCA (M1) arteries. Subjects are either ineligible for IV alteplase or have received IV alteplase therapy without recanalization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
206
Mechanical embolectomy in anterior large vessel occlusion
Standard of care in acute ischemic stroke including intravenous rTPA
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitario Vall D'Hebron
Barcelona, Barcelona, Spain
Hospital Clinic
Barcelona, Barcelona, Spain
Hospital Universitari Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Between-group comparison of the distribution of the modified Rankin Scale scores (shift analysis)
evaluated by two separate assessors who are blinded to treatment
Time frame: 90 days after enrollment
Mortality at 90 days
Time frame: 90 days after enrollment
Symptomatic Intracerebral Hemorrhage
Deterioration in NIHSS score of ≥4 points within 24 hours from treatment and evidence of intraparenchymal hemorrhage type 2 in the 22 to 36 hours follow-up imaging scans evaluated by independent CT/MR Core Lab and Clinical Events Committee
Time frame: 24h (-2/+12 hours) after enrollment
Infarct Volume
Infarct volume evaluated in a second neuroimaging after treatment evaluated by independent CT/MR Core Lab
Time frame: 24h (-2/+12h) post treatment
Vessel recanalization
Vessel recanalization evaluated by CT angiography or MRA at 24 hours in both treatment groups evaluated by independent CT/MR Core Lab
Time frame: 24h post treatment
Intraprocedural related complications in endovascular arm
Procedural related complications in the endovascular treatment arm: arterial perforation, arterial dissection, and embolization in a previously uninvolved vascular territory evaluated by the Angiography Core Lab and the Clinical Events Committee
Time frame: During endovascular treatment
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