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

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

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.

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