Prospective, Observational, Multi-Center, Single-Arm, Consecutive Enrollment, Post-Marketing, International Registry of the Surpass™ Flow Diverter in Intracranial Arteries
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 150
- 试验地点
- 19
- 主要终点
- Primary effectiveness based on the proportion of patients with 100% aneurysm occlusion
研究概览
简要总结
The purpose of this observational post-marketing registry will be to collect and analyze safety, effectiveness, and quality of life outcomes, during and after treatment with the Surpass Flow Diverter. Health Economics assessments (cost data) will also be collected and analyzed.
详细描述
This will be a prospective, observational, multi-center, single-arm, post-marketing, international registry with consecutive enrollment of a minimum of 150 patients treated with the Surpass Flow Diverter in accordance with the standard of care at up to 30 registry sites.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are to be treated with a Surpass Flow Diverter(s) will be eligible to participate in this registry. Patients will be enrolled on a consecutive basis.
排除标准
- •This is a standard of care registry. Patients should be excluded if standard of care at a given site is such that they are not eligible for treatment with a Surpass Flow Diverter(s).
结局指标
主要结局
Primary effectiveness based on the proportion of patients with 100% aneurysm occlusion
时间窗: 12 months
The proportion of patients with 100% aneurysm occlusion, based on an assessment of each patient's imaging at 12 months (± 180 days) post-procedure, and stratified across four aneurysm categories.
次要结局
- Technical success assessed by deployment of the device with complete coverage of the aneurysm neck(Peri-procedural)