Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total Navigation/procedure time
研究概览
简要总结
The purpose of this study is to evaluate the function of matched pair Aristotle 14 Guidewire and Plato Microcatheter in MMA embolization treatment for chronic subdural hematoma compared to surgeon's preference
详细描述
If you agree to take part, you will have a 50/50 chance of being assigned to one of two groups. In group 1, your procedure will use the study devices. In group 2, your procedure will use devices chosen by your surgeon. The procedure and follow up are part of standard medical care. This means that taking part in the study will not mean more time or energy compared to the usual treatment you would have.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Patient or legally authorized representative (LAR) signs an informed consent form
- •Confirmed diagnosis of subacute or chronic subdural hematoma, defined as 50% or more chronic blood
- •Pre-morbid Modified Rankin Score of ≤ 3
排除标准
- •Age < 18 years old
- •Potentially dangerous anatomic variations leading to increased procedural risk or unsafe access for MMA embolization
- •Unmanaged, uncontrolled bleeding disorders/blood diathesis
- •Presumed septic embolus, or suspicion of microbial superinfection
- •Contraindication to angiography
- •CT or MRI evidence of intra-cranial tumor or mass lesion
结局指标
主要结局
Total Navigation/procedure time
时间窗: 2 years
Comparing between devices on both navigation and procedure time
Final Embolization Grades
时间窗: 2 Years
Comparison between device groups for final embolization grades
Incidence of AE at time of surgery
时间窗: 2 Years
Incidence of device related adverse events and incidence of procedure related adverse events
Incidence of recurrence of hemorrhage
时间窗: 2 Years
Incidence of hematoma reoccurrence/progression requiring re-intervention at 90 day follow-up
次要结局
未报告次要终点
研究者
Patrick Youssef
M.D
Ohio State University