SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 3
- 主要终点
- Study Device-related Serious Adverse Events (SAEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient or patient's legally authorized representative has signed and dated an Informed Consent Form
- •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
排除标准
- •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
结局指标
主要结局
Study Device-related Serious Adverse Events (SAEs)
时间窗: 90 Day
Incidence of study device-related Serious Adverse Events (SAEs)
Procedure-related Serious Adverse Events (SAEs)
时间窗: 90 Day
Incidence of study procedure-related Serious Adverse Events (SAEs)
Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage
时间窗: 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)
次要结局
- Time to Initial Recanalization(post treatment)
- Good Neurological Outcome 90 Days(90 Days Follow-up)
- Symptomatic Intracranial Hemorrhage(24 hours)
- Good Neurological Outcome at 30 Days(30 Days Follow-up)
- Mortality(90 Days follow-up)
- Non-fatal Stroke-related Morbidity(90 Day)