Safety and Efficacy of the Percutaneous Intervention Performed With Devices of a Single-brand
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
- 否
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
Denise Oliveira
Principal Investigator, Assistent Cardiologist
Hospital Sao Lucas da PUCRS
