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临床试验/NCT01073111
NCT01073111
撤回
不适用

Assessment of Neointimal Stent Strut Coverage and Endothelial Function After Second Generation Drug-Eluting Stent Systems

Hyogo Medical University1 个研究点 分布在 1 个国家2010年4月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Coronary Artery Disease
发起方
Hyogo Medical University
试验地点
1
主要终点
To compare coronary endothelial function after primary angioplasty.
状态
撤回
最后更新
7年前

概览

简要总结

The purpose of this study is to compare coronary endothelium function in patients with a zotarolimus-eluting versus a sirolimus-eluting or a everolimus-eluting stents with optical coherence tomography, vasoconstriction in response to acetylcholine, and coronary biomarker level.

注册库
clinicaltrials.gov
开始日期
2010年4月
结束日期
2017年2月
最后更新
7年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Kenichi Fujii

Assistant Professor

Hyogo Medical University

入排标准

入选标准

  • Significant coronary de novo lesion (\> 70% by quantitative angiographic analysis)
  • Patients with stable or acute coronary syndrome considered for coronary revascularization
  • Reference vessel diameter of 2.5 to 3.5 mm by operator assessment

排除标准

  • Contraindication to anti-platelet agents
  • Ostial lesion within 5 mm from ostium
  • Different DES in other vessel simultaneously
  • Creatinine level 2.5 mg/dL
  • Left main stenosis more than 50%.
  • vein graft lesion
  • Triple vessel disease with stenosis more than 50% in 3 epicardial coronary arteries
  • Life expectancy 1 year
  • Reference vessel \< 2.5 mm or \> 4.0 mm diameter by visual
  • Long lesion that require more than three stents

结局指标

主要结局

To compare coronary endothelial function after primary angioplasty.

时间窗: 6 months and 12 months

To compare the presence of neointimal stent strut coverage via optical coherence tomography.

时间窗: 6 months and 12 months

To compare the serum biomarker levels measured in coronary artery blood.

时间窗: 6 months and 12 months

研究点 (1)

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