Use of Different Diagnostic Coronary Catheters Over the Radial Access - the UDDC - Radial Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Coronary angiography Duration (sec)
研究概览
简要总结
There is no evidence from prospective randomized clinical trials regarding the performance of conventional (two-catheter-concept; TCC) versus one-catheter-concepts (OCC) for invasive coronary angiography over the radial access.
The aim of the present trial is to evaluate the efficacy and safety of different one-catheter concepts by use of the BLK and Tiger catheter compared to a TCC using standard Judkins catheters in diagnostic coronary angiography via transradial access. Patients with stable angina pectoris will be randomly assigned to coronary angiography performed with the BLK or Tiger (OCC) or Judkins catheters (TCC). The primary endpoint is coronary angiography duration.
详细描述
The aim of the present trial is to evaluate the efficacy and safety of a one-catheter concept using the BLK (Terumo, Somerset, USA) or the Tiger catheter (Terumo, Somerset, USA) compared to the standard Judkins catheters in diagnostic coronary angiography by the transradial access. Patients with stable angina pectoris will be randomly assigned to coronary angiography performed with the BLK (Group I), Tiger (Group II) or Judkins catheters (Group III). Primary endpoint is the time duration (sec) that is necessary to perform complete coronary angiography including 6 different projections for the left-coronary system and 3 different projections of the right-coronary-system. Secondary endpoints will cover safety and imaging quality of the different catheter systems.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and ≤ 95 years
- •Body weight > 60kg
排除标准
- •Acute coronary syndrome or cardiogenic shock
- •Contraindications for transracial access such as absence of radial pulse or abnormal Allen test
- •Prior unsuccessful transradial coronary angiography
- •Estimated glomerular filtration rate <40 ml/kg/min
- •Patients not able to give informed consent
- •Participation in another trial
研究组 & 干预措施
BLK catheter
Coronary angiography will be performed with the BLK catheter (one-catheter concept).
干预措施: One-catheter concept (Device)
Tiger catheter
Coronary angiography will be performed with the Tiger catheter (one-catheter concept).
干预措施: One-catheter concept (Device)
Judkins catheter
Coronary angiography will be performed with the Judkins catheter (standard catheter).
干预措施: Standard catheter (Device)
结局指标
主要结局
Coronary angiography Duration (sec)
时间窗: Day 0 (corresponding to time point of procedure)
assessed by Intention-to-treat analysis (IIT)
次要结局
- Safety endpoints (kinking, radial spasm, vascular access complications, bleeding complications).(Day 0 (corresponding to time point of procedure))
- Imaging Quality (ostial stability, diagnostic value)(Day 0 (corresponding to time point of procedure))
- Cross over rate to another catheter or transfemoral access.(Day 0 (corresponding to time point of procedure))
- Contrast volume (ml)(Day 0 (corresponding to time point of procedure))
- Flouroscopy time (sec)(Day 0 (corresponding to time point of procedure))
研究者
David Manuel Leistner
MD
Charite University, Berlin, Germany