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临床试验/NCT01689688
NCT01689688Unknown不适用

Healing Response to Everolimus-eluting Stent Implantation; Serial Assessment With opticaL Coherence Tomography

Kobe University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
The percentage of neointimal coverage

研究概览

简要总结

The purpose of this study is to evaluate serial changes of neointimal coverage after everolimus-eluting stent implantation at 3-, 6- and 12-months by OCT examination.

详细描述

Late and very late stent thrombosis is current main issue after introduction of drug-eluting stents .Possible causes of these stent thromboses include thrombus formation resulting from delayed neointimal coverage, spasms occurring at the distal end of the stent implantation site, positive remodeling of coronary arteries caused by local immune reaction to paclitaxel or rapamycin, and vascular endothelial damage induced by the polymer. For BMS, neointimal coverage begins within the first one month after stent implantation and almost completes in three months. For DES, sirolimus eluting stents (SES) for example, neointimal coverage is markedly delayed after stent implantation and the exposed stent struts may be largely attributable to the occurrence of late stent thrombosis.

On the other hand, everolimus eluting stents (EES), which have a thinner stent strut layer and improved polymer biocompatibility, it has been reported that earlier and more normal neointimal coverage can be achieved compared with other first-generation DESs, SES and paclitaxel eluting stents (PES). These findings suggest that coverage with vascular endothelium differs among different DES platforms. Optical coherence tomography (OCT) has a resolution of 15 to 20 μm, which is approximately 10 times higher than that of intravascular ultrasound (IVUS). It is therefore necessary to use OCT to accurately evaluate cross-sectional images of the stent struts covered with vascular endothelium. However, no studies have reported the results of continuous observation and evaluation of EES covered with endothelium.

Therefore, the investigators investigate time course of neointimal coverage of EES through detailed evaluation by OCT of neointimal coverage at 3, 6, and 12 months after stent implantation.

研究设计

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

入排标准

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

入选标准

  • Older than 20 years old.
  • Indication of PCI.
  • To agree to review and record all the clinical course in this research protocol.
  • The patient who are eligible to receive dual antiplatelet therapy at least more than 6 month.
  • Informed concent with the document signed by the patients.
  • The patient have to correspond to all the above items at the time of registration.

排除标准

  • The patient who died during the research
  • The patient with Stent thrombosis during the research.
  • Previous history of pancytopenia, liver function, renal dysfunction, hypersensitive history of the drug.
  • Low ejection fraction (LVEF<=30%), an impaired liver function, and renal dysfunction (eGFR<=30)
  • The patient excluded from a safety of a thiazolidine derivative.
  • lesion exclusion criteria
  • left main artery
  • severe calcification
  • stent restenosis

结局指标

主要结局

The percentage of neointimal coverage

时间窗: 12 months

The primary endpoint is to evaluate the neointimal coverage of XIENCE everolimus eluting stent (EES) in 12 month after stent implantation by Optical coherence tomography

次要结局

  • The percentage of neointimal coverage(6 months)

研究者

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

Toshiro Shinke, MD, PhD

Associate Professor

Kobe University

研究点 (1)

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