SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Patient or patient's legally authorized representative has signed and dated an Informed Consent Form
Age22-85
Clinical signs consistent with acute ischemic stroke
National Institutes of Health Stroke Scale (NIHSS) ≥8and<30
Thrombolysis in Myocardial Infarction (TIMI) 0 or TIMI 1 flow in the M1 or M2 of middle cerebral artery, internal carotid artery, basilar or vertebral arteries confirmed by angiography that is accessible to the SOLITAIRETM or MERCI® Device
Patient is able to be treated within 8 hours of stroke symptoms onset with minimum of one deployment of the SOLITAIRETM or MERCI® Device.
Patient who is ineligible or failed intravenous tissue plasminogen activator (t-PA) therapy given at local institutions or within national practice.
Patient is willing to conduct follow-up visits

Exclusion Criteria

NIHSS > 30 or coma
Neurological signs that are rapidly improving prior to or at time of treatment
Females who are pregnant or lactating
Known serious sensitivity to radiographic contrast agents
Current participation in another investigation drug or device study
Uncontrolled hypertension defined as systolic blood pressure > 185 or diastolic blood pressure > 110 that cannot be controlled except with continuous parenteral antihypertensive medication
Use of warfarin anticoagulation with International Normalized Ratio (INR) > 3.0
Platelet count < 30,000
Glucose < 50 mg/dL
Arterial tortuosity that would prevent the device from reaching the target vessel
Life expectancy of less than 90 days
Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of hemorrhage on presentation
CT showing hypodensity or MR showing hyperintensity involving greater than 1/3 of the middle cerebral artery (MCA) territory (or in other territories, >100 cc of tissue) on presentation
CT or MRI evidence of mass effect or intracranial tumor (except small meningioma)
Angiographic evidence of carotid dissection, complete cervical carotid occlusions, or vasculitis

Arm && Interventions

Group	Intervention	Description
MERCI® Device	MERCI® Device	The MERCI® Device (control device) is commercially available.
SOLITAIRE™ Device	SOLITAIRE™ Device	The SOLITAIRE™ Device (investigational device) is the experimental arm

Primary Outcome Measures

Name	Time	Method
Study Device-related Serious Adverse Events (SAEs)	90 Day	Incidence of study device-related Serious Adverse Events (SAEs)
Procedure-related Serious Adverse Events (SAEs)	90 Day	Incidence of study procedure-related Serious Adverse Events (SAEs)
Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage	Immediately post treatment	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)

Secondary Outcome Measures

Name	Time	Method
Mortality	90 Days follow-up	Rate of Mortality
Time to Initial Recanalization	post treatment	Time from guide catheter placement to first visualization of Thrombolysis in Myocardial Infarction (TIMI) 2 flow
Good Neurological Outcome 90 Days	90 Days Follow-up	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
Symptomatic Intracranial Hemorrhage	24 hours	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.
Good Neurological Outcome at 30 Days	30 Days Follow-up	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
Non-fatal Stroke-related Morbidity	90 Day	Morbidity data is presented in terms of subjects with permanent deficit as a result of one or more adverse events