Transradial Versus Transfemoral Arterial Access for Cerebral Angiography
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 748
- 试验地点
- 1
- 主要终点
- the rate of successful diagnostic cerebral angiography
研究概览
简要总结
This study is multi-center, prospective, randomized (1:1) controlled trial designed to assess and compare the feasibility, safety and success of Transradial access (TRA) versus Transfemoral access (TFA) for diagnostic cerebral angiography.
详细描述
TFA is traditional approach for diagnostic cerebral angiography, which has several limitations and complications including pain and discomfort, retroperitoneal hemorrhage, pulmonary embolism and increased admissions. Transradial coronary angiography has demonstrated preponderance to circumvent this limitations and complications. However, this has not been studied in cerebral angiography. So, the purpose of this study is to assess and compare the feasibility, safety and success of TRA versus TFA for diagnostic cerebral angiography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-90 years
- •Planned cerebral angiography for clinical reason
- •Eligible for either transfemoral or transradial approach
- •Accept to sign the written consent form (WCF)
排除标准
- •Contraindications to cerebral angiography, such as allergy to iodine contrast agents and renal insufficiency (GFR < 30 ml/min), etc.;
- •Failure to complete the follow-up as required by the protocol;
- •Urgency/Emergency procedure
- •Patients are participating in other clinical trials;
- •Being pregnant or plan to get pregnant in the short term.
结局指标
主要结局
the rate of successful diagnostic cerebral angiography
时间窗: 24 hours
the successful superselection of the aortic arch vessel without changing the arterial approach, with angiography results meeting diagnostic requirements
次要结局
- the rate of successful accurate diagnosis(24 hours)
- the duration of angiography(During procedure)
- the duration of fluoroscopy(During procedure)
- the bedridden time(24 hours)
- the Visual Analogue Scale (VAS) score(24 hours)
研究者
Yuxiang Gu
Vice-president of Huashan Hospital west campus
Huashan Hospital