Comparison of Headache After Coil Embolization for Unruptured Intracranial Aneurysms (Standard Versus Stent-assisted): A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- severity of headache after coil embolization between 2 arms
研究概览
简要总结
Perform a prospective cohort study to compare the incidence and severity of headache between non-stent assisted coiling and stent assisted coiling of unruptured intracranial aneurysms.
详细描述
severity of headache - assess with visual analogue scale characteristics of headache after stent deployment or simple coiling Duration of headache after intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with unruptured intracranial aneurysms
- •patients over 20 years old
- •patients who can communicate with each other
- •patients who agreed to this study (with informed consent)
排除标准
- •patients with recurrent aneurysms after coiling or clipping
- •patients with allergic reaction to antiplatelets
- •patients with high risks of hemorrhage
- •patients with coagulopathy
- •patients with thrombocytopenia (<100,000/mm3)
- •patients with liver disease (> 100 of aspartate aminotransferase or alanine aminotransferase)
- •patients with renal disease (> 2mg/dL of serum creatinine)\
- •patients with uncontrolled heart failure or angina
- •patients with malignant tumor
- •pregnant patients
- •patients with past history that may associated with headache, including subarachnoid hemorrhage, head trauma, intracerebral hemorrhage, trigeminal neuralgia, arteriovenous malformation, brain tumor)
- •Patients who are determined to be disqualified by researchers
研究组 & 干预措施
non-stent assisted coiling
patients treated with non-stent assisted coiling of unruptured intracranial aneurysms
干预措施: non-stent assisted coiling (Procedure)
stent assisted coiling
patients treated with stent assisted coiling of unruptured intracranial aneurysm
干预措施: stent assisted coiling (Procedure)
结局指标
主要结局
severity of headache after coil embolization between 2 arms
时间窗: prior to intervention / immediate after procedures / postoperative days 3, 7, 14, 90 days
check change of severity of headache after coil embolization between 2 arms
次要结局
- Duration of headache after coiling embolization after intervention(Measure the duration of time from when a headache occurs to when it disappears, assessed up to 3 months)
- characteristics of headache after coiling embolization between 2 arms(prior to intervention / immediate after procedures / postoperative days 3, 7, 14, 90 days)