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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: SOLITAIRE™ Device
* Device: MERCI® Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOLITAIRE™ Device<br>The SOLITAIRE™ Device (investigational device) is the experimental arm | Device: SOLITAIRE™ Device<br>* The SOLITAIRE™ Device is the experimental device that will be used in the interventional procedure<br>|
| Active Comparator: MERCI® Device<br>The MERCI® Device (control device) is commercially available. | Device: MERCI® Device<br>* The MERCI® Device is the control device that will be used in the interventional procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Immediately post treatment | 
| Study Device-related Serious Adverse Events (SAEs) | Incidence of study device-related Serious Adverse Events (SAEs) | 90 Day | 
| Procedure-related Serious Adverse Events (SAEs) | Incidence of study procedure-related Serious Adverse Events (SAEs) | 90 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Initial Recanalization | Time from guide catheter placement to first visualization of Thrombolysis in Myocardial Infarction (TIMI) 2 flow | 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 | 30 Days Follow-up | 
| Good Neurological Outcome 90 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 | 90 Days Follow-up | 
| Mortality | Rate of Mortality | 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. | 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 | 90 Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic Stroke, SOLITAIRE™ Device, SOLITAIRE™, MERCI® Device, MERCI®, Stroke, Ischemic, Mechanical Thrombectomy, Brain, Brain Clot, Brain Artery Revascularization, Recanalization, Brain Stroke, Clot Retriever, Device, Neurosurgery, Neurovascular Intervention, Interventional Neuroradiology, Brain study, neurovascular clinical trial