AcandiS Stenting of Intracranial STENosis - regisTry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Acandis GmbH
- 入组人数
- 150
- 试验地点
- 16
- 主要终点
- Rate of Technical Success
研究概览
简要总结
ASSISTENT is designed to collect comprehensive information on technical and clinical safety of the use of Credo® stent together with the NeuroSpeed® PTA balloon catheter in clinical practice in an open registry.
详细描述
ASSISTENT is subdivided into two components. The first part only requires recording of data acquired in routine clinical practice during the treatment of patients with intracranial stenosis with the self-expandable Credo® stent until discharge. This comprises demographic data, data concerning the qualifying clinical event, limited data on medical history and medication, information about the intervention including technical success and periprocedural complications or events, and information about events and clinical status during the in-hospital treatment until hospital discharge.
The second part of the registry consists of a follow-up visit 30 days after the interventional procedure which will be conducted outside of clinical practice.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment with Credo® for symptomatic atherosclerotic intracranial artery stenosis (see product IFU)
排除标准
- •There are no specific exclusion criteria (see product IFU)
结局指标
主要结局
Rate of Technical Success
时间窗: During interventional procedure
• Technical Success
Number of Patients with Cerebrovascular events
时间窗: At hospital discharge - befor the patient leaves the hospital after the intervention; up to 2 weeks, whichever came first
* Intracranial haemorrhage (symptomatic / asymptomatic) * Death * TIA in the region of the target vessel * Non-disabling ischemic stroke (MRS 0-2) in the region of the target vessel * Disabling ischemic stroke (MRS 3-6) in the region of the target vessel * TIA outside the region of the target vessel * Non-disabling ischemic stroke (MRS 0-2) outside the region of the target vessel * Disabling ischemic stroke (MRS 3-6) outside the region of the target vessel
Number of Patients with Periprocedural Vascular Events
时间窗: Periprocedural, until 30 days after the interventional procedure
* Intracranial haemorrhage (symptomatic / asymptomatic) * Death * TIA in the region of the target vessel * Non-disabling ischemic stroke (MRS 0-2) in the region of the target vessel * Disabling ischemic stroke (MRS 3-6) in the region of the target vessel * TIA outside the region of the target vessel * Non-disabling ischemic stroke (MRS 0-2) outside the region of the target vessel * Disabling ischemic stroke (MRS 3-6) outside the region of the target vessel
Number of Patients with Cerebrovascular Events
时间窗: 30 days after the interventional procedure
* Intracranial haemorrhage (symptomatic / asymptomatic) * Death * TIA * Non-disabling ischemic stroke (MRS 0-2) * Disabling ischemic stroke (MRS 3-6) * Interventional re-treatment of the target vessel
次要结局
- Number of Patients with Occlusion of the target vessel(30 days after the interventional procedure)
- Number of Patients with Dissection of the target vessel(During interventional procedure)
- Number of Patients with Myocardial infarction(30 days after the interventional procedure)
- Number of Patients with Severe extracranial hemorrhage (requiring surgical treatment or transfusion)(30 days after the interventional procedure)