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临床试验/NCT00821106
NCT00821106已完成不适用

Transradial Approach [LEft vs Right] aNd Procedural Times During Percutaneous Coronary Procedures: TALENT Study

Policlinico Casilino ASL RMB2 个研究点 分布在 1 个国家目标入组 1,540 人开始时间: 2009年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,540
试验地点
2
主要终点
Primary end point of the study is the fluoroscopy time of the procedure and the radiation dose adsorbed by the patients

研究概览

简要总结

Transradial approach of cardiac catheterization is a common alternative to transfemoral access for diagnostic coronary angiography and percutaneous coronary interventions (PCI). The transradial approach reduces access site bleeding complications and the procedural discomfort of the patients. Transradial procedures may be performed by cannulation of the right or left radial artery and at present, the choice of the right or left radial artery depends largely on the operator' s preference.

The aim of this study is to evaluate safety and efficacy of transradial approach comparing the right radial versus the left radial approach in coronary diagnostic and interventional procedures.

The investigators will enroll consecutively for 12 months all patients who undergo to diagnostic or interventional procedures through trans radial approach in two Italian centers (Casilino Policlinic, Catholic University-Rome).

Primary end point of the study is the fluoroscopy time and the radiation dose adsorbed by the patients. Secondary end-points are: contrast amount, time to obtain the first angiography, procedural shift rate, number of catheters employed, major complications.

The investigators pre-specified a sub-study in patients older than 75 years old with the same end-points.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients who undergo to diagnostic or interventional procedures

排除标准

  • Previous coronary artery by-pass
  • Acute myocardial infarction with ST segment elevation myocardial infarction
  • Cardiogenic shock
  • Ischemic Allen Test

结局指标

主要结局

Primary end point of the study is the fluoroscopy time of the procedure and the radiation dose adsorbed by the patients

时间窗: 7 days

次要结局

  • Contrast amount, time to obtain the first angiography, procedural shift rate, number of catheters employed, major complications.(7 days)

研究者

发起方
Policlinico Casilino ASL RMB
申办方类型
Other

研究点 (2)

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