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临床试验/NCT00738556
NCT00738556已完成不适用

Spot Drug-Eluting vs Full Cover Stenting for Long Coronary Stenoses: a Randomized Clinical Study

Cardiovascular Research Society, Greece2 个研究点 分布在 1 个国家目标入组 179 人开始时间: 2003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
179
试验地点
2
主要终点
Major adverse cardiac events

研究概览

简要总结

Most doctors who use the new drug-eluting stents for the treatment of long coronary narrowings tend to cover the full length of the lesion with long or multiple stents. The investigators hypothesized that a policy of spot-stenting, i.e., stenting of only the very tight parts of the coronary narrowing, might result in better outcomes by means of avoiding multiple stents that have been associated with significant complications such as late stent thrombosis.

详细描述

Coronary artery lesion length is an independent predictor of restenosis following coronary intervention and the deployment of multiple or long bare metal stents has been associated with an increased risk of adverse clinical outcome. Spot stenting, ie discrete stenting of only the most severe stenoses of long, diffuse lesions has been proposed as an alternative in this clinical setting. The introduction of drug-eluting stents has resulted in longer lesions being stented and the use of multiple, overlapping DES in patients with diffusely diseased coronary arteries has been considered safe and effective. However, there has also been evidence of increased major adverse cardiac events (MACE) with the use of multiple, overlapping DES,10-12 while long DES have been associated with increased probability of intraprocedural stent thrombosis.13 We hypothesized that an approach based on spot-stenting with the use of DES might result in superior clinical outcomes compared to full cover of atheromatic lesions with long or multiple stents. We are therefore conducting a randomized comparison of spot versus multiple overlapping stenting on consecutive patients with long (>20 mm) lesions and indications for percutaneous coronary intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consenting, consecutive patients with a de novo, native coronary artery lesion longer than 20 mm.

排除标准

  • Unprotected left main coronary artery stenosis,
  • Left ventricular ejection fraction <25%, OR
  • Contraindication to aspirin or clopidogrel

结局指标

主要结局

Major adverse cardiac events

时间窗: 3 years

次要结局

未报告次要终点

研究者

发起方
Cardiovascular Research Society, Greece
申办方类型
Other

研究点 (2)

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