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临床试验/NCT01942044
NCT01942044Unknown4 期

Impact of Stent Platform on Shear Stress Distribution and Subsequent Vessel Healing After Drug-eluting Stent Implantation (SHEAR DES)

Kobe University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
4 期
入组人数
30
试验地点
2
主要终点
Percentage of uncovered struts

研究概览

简要总结

The purpose of this study is to evaluate the differences of wall shear stress distribution among different types of drug-eluting stents and its impact on vessel healing evaluated by intravascular optical coherence tomography evaluation.

详细描述

Background: Distribution of wall shear stress (WSS) may be different according to stent designs. The impact of WSS after stent implantation may impact future vessel healing after current generation drug-eluting stents implantation. Although previous studies used IVUS (intravascular ultrasound) and angiography to determine WSS from computational fluid dynamics (CFD) simulations, new methods using higher resolution OCT (optical coherence tomography) are warranted to further evaluate the impact of stent design on WSS with current generation drug-eluting stents.

Methods: For these purpose, we will enroll a total of 30 patients with stable angina who are scheduled for percutaneous coronary intervention. Those patients were randomized to thin-strut (81μm) 2-link Promus element (PE: n=10), thin-strut (81μm) 3-link Xience Prime (XP: n=10), or thick-strut (145μm) 2-link Nobori stents (NO: n=10) and underwent OCT and coronary CT angiography (CTA) after stenting. Post stent WSS was calculated using CFD simulations based on patient-specific reconstructed 3D arteries created by the fusion of OCT and CTA data, normalized using WSS in the proximal unstented region. Also, follow-up angiography and OCT are performed for the assessment of vessel healing as well as WSS distribution 8months after stent implantation.

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
Single (Investigator)

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 with Xience prime, Nobori, or Promus element.
  • Clinical diagnosis of stable angina, unstable angina or silent ischemia with reference vessel diameters ranging from 2.5-3.5mm.
  • Underwent CT angiography before PCI.
  • To agree to review and record all the clinical course in this research protocol.

排除标准

  • 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<=40)
  • Severe calcification
  • Stent restenosis

结局指标

主要结局

Percentage of uncovered struts

时间窗: 8 months

次要结局

  • Neointimal thickness(8 months)
  • Area of low wall shear stress(8 months)
  • The percentage of malapposed struts(8 months)
  • Area of high oscillatory shear index(8 months)

研究者

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

Hiromasa Otake

Assistant Professor

Kobe University

研究点 (2)

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