Safety and Efficacy of the Surpass Evolve Flow Diverter in Treating Intracranial Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Complete aneurysm occlusion rate
研究概览
简要总结
Safety and Efficacy of the Surpass Evolve Flow Diverter in Treating Intracranial Aneurysms
详细描述
This study aims to retrospectively evaluate the efficacy and safety of the Surpass Evolve Flow Diverter in treating complex intracranial aneurysms. It seeks to assess long-term outcomes and complication rates while analyzing the impact of patient characteristics and aneurysm types on treatment effectiveness. By collecting data from multiple centers, the study ensures broad representativeness, ultimately providing valuable insights for clinical management on a global scale.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years with a confirmed diagnosis of intracranial aneurysm.
- •Imaging studies confirming suitability for Surpass Evolve Flow Diverter treatment.
- •Aneurysms meeting flow diverter treatment indications (e.g., aneurysms larger than 4 mm).
- •At least six months of follow-up data available post-treatment.
排除标准
- •Patients with acutely ruptured aneurysms or significant bleeding.
- •Patients with incomplete data or insufficient follow-up records.
结局指标
主要结局
Complete aneurysm occlusion rate
时间窗: 12(-3 ~ +6) months
Favorable prognosis rate
时间窗: 12(-3 ~ +6) months
mRS score 0-1
Procedure-related complication rate
时间窗: 12(-3 ~ +6) months
次要结局
- Procedural success rate(12(-3 ~ +6) months)
- Perioperative complication rate(12(-3 ~ +6) months)
- Neurological mortality rate(12(-3 ~ +6) months)
- Incidence of postoperative stroke/TIA(12(-3 ~ +6) months)
- Rates of postoperative intracranial hemorrhage and neurological deficits(12(-3 ~ +6) months)
研究者
Yibin Fang
Dr.
Shanghai Fourth People's Hospital Tongji University