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临床试验/NCT05584280
NCT05584280已完成不适用

Systematic Post-Implementation Evaluation of Stents

Vastra Gotaland Region1 个研究点 分布在 1 个国家目标入组 1,067 人开始时间: 2022年12月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,067
试验地点
1
主要终点
Cost effectiveness ratio (percent)

研究概览

简要总结

To conduct a quality assurance project to establish the differences in health care processes and cost effectiveness of having the thin-strut Orsiro stent versus the thicker strut Promus stent on the shelf (i.e. as the most accessible stent).

详细描述

Background:

Individual patient-level randomized trials have suggested that the ultrathin strut Orsiro stent is associated with a lower risk of adverse ischemic events than the thin strut Promus stent. However, there are theoretical advantages of each stent in regards to usability, delivery and radial strength.

Study design:

The SPECS trial is a prospective, open-label, cross-sectional, cluster randomized quality assurance project, in which cardiac catheterization laboratories (hereafter referred to as center) in Västra Götaland Sweden will participate. Each week each center will place either Orsiro or Promus in the shelf in the cath lab as the most accessible stent (their workhorse stent). The specific stent to be placed on the shelf at each center each week will be randomly decided.

All patients will be treated according to local treatment guidelines and at the discretion of the interventional cardiologists, including the choice of stents.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Patients undergoing PCI at any hospital participating in the study

排除标准

  • 未提供

研究组 & 干预措施

Orsiro stent on shelf

Treatment

干预措施: Orsiro stent on shelf (Device)

Promus stent on shelf

Control

干预措施: Promus stent on shelf (Device)

结局指标

主要结局

Cost effectiveness ratio (percent)

时间窗: 1 year

Cost effectiveness of Orsiro compared to Promus on shelf.

次要结局

  • How many additional units were needed?(During the procedure)
  • How many patients were treated?(1 week)
  • Composite of all-cause death, myocardial infarction, or coronary revascularization(1- year)
  • How long time did the procedure take?(During the procedure)
  • How many other stents were used?(During the procedure)

研究者

发起方
Vastra Gotaland Region
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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