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.
Trial Stopped: Following DSMB advice after first interim analysis (n=174)
- Solitaire FR device Device
Intervention Desc: Mechanical embolectomy in anterior large vessel occlusion ARM 1: Kind: Experimental Label: Endovascular treatment Description: Mechanical embolectomy with Solitaire FR device
- Medical treatment Drug
Intervention Desc: Standard of care in acute ischemic stroke including intravenous rTPA ARM 1: Kind: Experimental Label: Medical treatment Description: Medical treatment (standard of care in acute ischemic stroke)including intravenous thrombolysis
- Allocation: Randomized
- Masking: Single Blind (Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Between-group comparison of the distribution of the modified Rankin Scale scores (shift analysis)||90 days after enrollment||No|
|Secondary||Mortality at 90 days||90 days after enrollment||Yes|
|Secondary||Symptomatic Intracerebral Hemorrhage||24h (-2/+12 hours) after enrollment||Yes|
|Secondary||Infarct Volume||24h (-2/+12h) post treatment||No|
|Secondary||Vessel recanalization||24h post treatment||No|
|Secondary||Intraprocedural related complications in endovascular arm||During endovascular treatment||Yes|