Transradial Versus Transfemoral Access for Cerebral Angiography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years old;
- •Scheduled to undergo diagnostic cerebral angiography;
- •Suitable for cerebral angiography via TRA and TFA access, with a radial artery diameter ≥2mm confirmed by ultrasonography;
- •Modified Rankin Scale (mRS) score ≤2;
- •Provided written informed consent.
排除标准
- •Severe stenosis of the radial, brachial, subclavian, brachiocephalic, iliac or common femoral arteries, or any significant vascular disease (such as aortic aneurysm, etc.) that may obstruct guidewire passage;
- •Arteriovenous fistula for hemodialysis present in the right upper limb;
- •Planned interventional surgery within 24 hours of the initial study angiography;
- •Requirement for cerebral angiography in an emergency department;
- •Use of general anesthesia;
- •Any contraindication to cerebral angiography, such as allergy or intolerance to the contrast media, uncorrected severe coagulation disorders, arterial dissection in the target vessel, puncture site infection, or renal insufficiency (Creatinine [Gr] > 3 times of the upper limit of normal [ULN]), etc.;
- •Women who are pregnant or planning to become pregnant within 1 year;
- •Participation in another clinical trial;
- •Any other condition deemed unsuitable for participation by the investigator.
研究组 & 干预措施
Trans-radial artery access
干预措施: Trans-radial access (Procedure)
Trans-femoral Artery access
干预措施: Trans-femoral access (Procedure)
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 duration of angiography(During procedure)
- the rate of successful accurate diagnosis(24 hours)
- 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