Left Radial comparEd to Femoral Approach for CORonary Angiography in Patients With Previous CABG StuDy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Net Procedure Time
研究概览
简要总结
This randomized, multicenter, prospective study seeks to compare left radial and femoral access during cardiac catheterization of patients with prior history of CABG surgery, with the primary objective of demonstrating that the two access techniques do not differ in the net procedure time (non-inferiority study) expanding the documented benefits of radial access to this group of patients.
详细描述
Patients from 4 different centers with a history of CABG are randomized 1:1 to left radial or femoral access. Based on the literature, a randomized study sample of a total of 150 patients was calculated with assumptions of 30 +/- 10-minute duration of the procedure, alpha = 5%, beta = 10% (power 90%) and non-inferiority limit Δ = 5 minutes. The primary endpoint of the study is the time it takes after placing the sheath at the initial puncture site until the completion of the diagnostic procedure (Net procedure time). Secondary endpoints include total time of the procedure, fluoroscopy time, total patient exposure radiation, amount of contrast used, possible vascular complications, major cardiovascular events and need for crossover access site.
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 over 18 years
- •Written informed consent
- •Clinical indication for coronary angiography in a patient with prior history of CABG
- •Left radial artery has not been used as a graft during CABG
排除标准
- •Age over 90 years
- •Patient's refusal to participate in the study
- •Hemodynamic instability of the patient
- •Failure to place a sheath at the randomization access site
- •Arteriovenous fistula at the left upper limb
- •Use of right internal mammary artery as a graft during CABG
- •Creatinine clearance <30 ml/min
研究组 & 干预措施
Femoral access
Femoral approach for coronary angiography in patients with prior history of CABG surgery
干预措施: Coronary Angiography (Procedure)
Left Radial access
Left Radial approach for coronary angiography in patients with prior history of CABG surgery
干预措施: Coronary Angiography (Procedure)
结局指标
主要结局
Net Procedure Time
时间窗: 24 hours
The time (min) after placement of the sheath at the initial puncture site until the completion of the diagnostic coronary angiography
次要结局
- Major Cardiovascular Events(24 hours)
- Total Procedure Time(24 hours)
- Fluoroscopy Time(24 hours)
- Dose Area Product(24 hours)
- Contrast Volume(24 hours)
- Vascular Complications(24 hours)
- Crossover access site(24 hours)
研究者
Tsigkas Grigorios
Interventional Cardiologist
University Hospital of Patras