An International Registry of the Wingspan™ Stent System for the Treatment of Intracranial Atherosclerotic Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 19
- 主要终点
- Successful Wingspan™ Stent Implantation (Access to the Lesion With the Stent, Accurate Deployment of the Stent Across the Target Lesion)
研究概览
简要总结
The IRISS study is designed to collect clinical and angiographic outcomes data when stenting intracranial atherosclerotic lesions using the Wingspan™ Stent System with Gateway™ PTA Balloon Catheter in routine clinical practice.
详细描述
The Wingspan™ Stent System and Gateway™ PTA Balloon Catheter have CE mark and are commonly used in Europe. All the data collected in this registry will be from patients treated according to the physician's choice, per instructions for use, per approved indications and per local standard of care. The results from this registry will provide an understanding of the use and outcomes associated with the Wingspan™ Stent in a real world setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 41 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic stenosis of one of those intracranial arteries: Internal carotid artery (ICA ), M1 segment of the MCA, V4 segment of vertebral artery, basilar artery
- •A Modified Rankin Score of ≤ 3
- •A target vessel diameter between 2mm and ≤ 4.5mm
- •Length of the target lesion of ≤ 14 mm
- •Patient older than 40 years old
排除标准
- •Patient previously stented at the target lesion
- •Intracranial stenosis related to disease such as: arterial dissection, Moya Moya disease, vasculitis, radiation induced vasculopathy or fibromuscular dysplasia
- •Complete occlusion of the artery on the imaging assessment
- •Contraindications to antithrombotic and/or anticoagulant therapies
- •Women who are pregnant or breast-feeding
- •Patient not likely to be available for follow-up
- •Patient protected by the law (safeguard of justice, supervision or trusteeship)
结局指标
主要结局
Successful Wingspan™ Stent Implantation (Access to the Lesion With the Stent, Accurate Deployment of the Stent Across the Target Lesion)
时间窗: Peri-procedural
The number of Wingspan Stents successfully deployed across the target lesion.
Cumulative Morbidity and Mortality Rate (Ischemic Event, Parenchymal Brain Hemorrhage, Subarachnoid or Intraventricular Hemorrhage or Death)
时间窗: 30 days
Any stroke or neurological death at \</= 30 days will be included in the cumulative morbidity and mortality rate. There was a 14.6% rate of cumulative morbidity and mortality at 30 days comprised of 12 events/82 patients.
Rate of Recurrent Ischemic Stroke in the Target Territory
时间窗: 12 Months
The rate of recurrent ischemic stroke from 31 days to 12 months post procedure was 1.3% or 1 event per 77 patients analyzed.
次要结局
- Cumulative Stroke Rate at 12 Months(12 months)
- Rate of Restenosis(12 Months)