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临床试验/NCT01201369
NCT01201369已完成不适用

Comparison of Rates of Strut Malapposition Between Everolimus and Sirolimus Eluting Stents - A Randomised Optical Coherence Tomography Study

Royal Brompton & Harefield NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Stent strut malapposition (SSM)

研究概览

简要总结

Despite recent advances in stent technology and clot reducing drug therapy, acute stent occlusion or thrombosis (ST), still occurs and can be life threatening. It has been shown that certain features of how the stent relates to the artery wall may predict ST. One such feature, so-called stent strut malapposition (SSM), can be assessed after implantation but current imaging techniques are relatively unreliable. Optical Coherence Tomography (OCT) is a newer technology that can be performed safely and easily after angioplasty and may allow the stent struts to be assessed more accurately and reliably.

This study will use OCT to examine how two different types of commonly used drug-eluting stents relate to the artery wall. The Xience V (Abbott Vascular, USA) stent has thinner struts and a more open frame than the Cypher (Cordis, USA) stent. We hypothesise therefore that the potentially more pliable structure of the Xience V stent will be associated with greater contact with the vessel wall. This may have a bearing on the relative rate of SSM, although large studies have shown the rate to be low in both the Cypher and the Xience V stent. We believe that OCT imaging of SSM and symmetry of the stent immediately after angioplasty will compliment conventional visual assessment and may identify those patients in whom further improvement of stent with a balloon is necessary.

This study will involve the random allocation of forty patients requiring coronary angioplasty to one of the Cypher or Xience V stent. The procedure will be performed in the usual manner as indicated clinically and will include imaging of the stented artery segment with OCT once the operator is satisfied with the visual result by angiography.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of a coronary artery stenosis undergoing percutaneous coronary intervention and stenting (PCI).
  • Eligibility for drug eluting stent (DES) deployment.
  • Stable or unstable coronary syndrome presentation, including ST elevation myocardial infarction (STEMI).
  • Aged 18-90

排除标准

  • Contraindication to the use of a DES.
  • Target lesion located within previous stent (in stent restenosis).
  • Sustained haemodynamic instability following stent deployment (Systolic BP 90≤ mmHg or sustained ventricular arrhythmia).

结局指标

主要结局

Stent strut malapposition (SSM)

时间窗: Immediate post stent deployment during the same angiographic procedure within 60 minutes

SSM will be quoted as the percentage of malapposed stent struts as a proportion of the total number of struts analysed within each stent group.

次要结局

  • Stent eccentricity index (SEI)(Immediate post stent deployment during the same angiographic procedure within 60 minutes)
  • Degree of stent embedding(Immediate post stent deployment during the same angiographic procedure within 60 minutes)

研究者

研究点 (2)

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