The purpose of this study is to demonstrate substantial equivalence of the SOLITAIRE™ FR Revascularization Device (SOLITAIRE™ Device) with a legally marketed device, MERCI Retrieval System® (MERCI® Device). The study will demonstrate safety and efficacy of the SOLITAIRE™ Device in subjects requiring mechanical thrombectomy diagnosed with acute ischemic stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
144
The SOLITAIRE™ Device is the experimental device that will be used in the interventional procedure
The MERCI® Device is the control device that will be used in the interventional procedure.
Oregon Stroke Center
Portland, Oregon, United States
Multicare Health System
Tacoma, Washington, United States
Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage
Successful arterial recanalization of occluded target vessel measured by Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following the use of the SOLITAIRE™ or MERCI® Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes. Thrombolysis in Myocardial Infarction (TIMI) score describes the distal flow perfusion and revascularization before and following therapy. TIMI 0 - No perfusion (worst outcome) TIMI 1 - Perfusion past the initial occlusion, but no distal branch filling TIMI 2 - Perfusion with incomplete or slow distal branch filling TIMI 3 - Full perfusion with filling of all distal branches (best outcome)
Time frame: Immediately post treatment
Study Device-related Serious Adverse Events (SAEs)
Incidence of study device-related Serious Adverse Events (SAEs)
Time frame: 90 Day
Procedure-related Serious Adverse Events (SAEs)
Incidence of study procedure-related Serious Adverse Events (SAEs)
Time frame: 90 Day
Time to Initial Recanalization
Time from guide catheter placement to first visualization of Thrombolysis in Myocardial Infarction (TIMI) 2 flow
Time frame: post treatment
Good Neurological Outcome at 30 Days
Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more
Time frame: 30 Days Follow-up
Good Neurological Outcome 90 Days
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Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more
Time frame: 90 Days Follow-up
Mortality
Rate of Mortality
Time frame: 90 Days follow-up
Symptomatic Intracranial Hemorrhage
Symptomatic hemorrhage within 24 hours of procedure. Symptomatic hemorrhages is defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a worsening of National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24hrs.
Time frame: 24 hours
Non-fatal Stroke-related Morbidity
Morbidity data is presented in terms of subjects with permanent deficit as a result of one or more adverse events
Time frame: 90 Day