跳至主要内容
临床试验/NCT01632501
NCT01632501已完成不适用

Safety and Efficacy of the Percutaneous Intervention Performed With Devices of a Single-brand

Hospital Sao Lucas da PUCRS0 个研究点目标入组 84 人开始时间: 2011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
入组人数
84
主要终点
Occurrence of: need to change the materials during the procedure (angioplasty).

研究概览

简要总结

The freedom of choice in medicine is based on the physician's ability to treat their patients with the best available therapy. The armamentarium for percutaneous intervention is frequently determined on the basis of subjective criteria and the experience of the interventional cardiologist. The evaluation of devices used in coronary intervention, especially angiography and its clinical outcomes, has rarely been investigated; the exceptions are studies on stents. Therefore, the freedom of choice for the interventional cardiologist has been challenged, especially because of cost restrictions. This way this study aims to assess the safety and efficacy of a device of a single brand in performing percutaneous transluminal coronary angioplasty (guide catheters, guidewires, balloons, and stents) in selected patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • The study included both male and female patients for stent implantation referred for angioplasty of coronary arteries with more than 18 years.

排除标准

  • chronic total occlusion angioplasty,
  • saphenous graft angioplasty,
  • bifurcation angioplasty (lateral branch greater than 1.5 mm)
  • plans to perform angioplasty on more than one vessel during the same procedure
  • and primary angioplasty in acute myocardial infarction

结局指标

主要结局

Occurrence of: need to change the materials during the procedure (angioplasty).

时间窗: 12 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Denise Oliveira

Principal Investigator, Assistent Cardiologist

Hospital Sao Lucas da PUCRS

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