Effectiveness of the Tiger Catheter as a Simple Multipurpuse Catheter in Transradial Coronariography: Randomized Comparerd to Judkins Catheters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Produce time for the coronary angiography
研究概览
简要总结
The aim of this study was to assess effectiveness and safety of Tiger (5Fr) vs Judkins (5Fr) catheters, in coronariography via the right transradial approach.
This was a prospective, randomized, study of paralled design. Consecutive patients with acute coronary syndrome (ACS), eligible for coronary angiography, was randomized after successuful cannulation of right artery and informed consent to either Tiger or Judkins catheters.
详细描述
analyzed a total of 120 consective diagnostic coronary angioggraphy cases from the right radial approach. Of these 60 cases were performed with single catheter (Tiger) and 60 cases were performed with conventional catheters (Judkins). The patients of both group were overall well balanced for gender, age, risk factors, height, weight and body surface area. Diagnostic angiograms were successfully achieved in all cases via the radial approach.
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
- Single (Participant)
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
- •written informed consent
- •indication for coronary angiography
排除标准
- •negative Allen´s test
- •Chronic renal failure (to preserve the right radial artery for potencial arteriovenous shunting)
- •Hemodynamic instability
- •coronary artery bypass grafting
研究组 & 干预措施
Tiger catheter
Tiger simple multipurpose catheter compared to Judkins catheters
干预措施: Tiger catheter (Device)
Judkins catheter
Judkins right and judkins left catheter
干预措施: Judkins catheter (Device)
结局指标
主要结局
Produce time for the coronary angiography
时间窗: Day 0 (corresponding to time point of produce) assessed by intention - to - tresat analysis (IIT)
Produce time (min) was defined as the time from the insertion of the first diagnostic coronary catheter in the sheath to the exist of the las diagnostic catheter the sheath.
次要结局
- Radial artery Spasm(Day 0 (corresponding to time point of produce). The radial artery spasm was recorded like YES or NOT.(registry did by nurse from beginning to end of coronary angiography))
- Fluoroscopy time(Day 0 (corresponding to time point of produce))
- Contrast Volume used(Day 0 (corresponding to time point of produce))
研究者
Marcelo Alberto OLIVA
interventional cardiologist
Hospital San Roque