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临床试验/NL-OMON38428
NL-OMON38428
尚未招募
不适用

Vascular Response to Everolimus-eluting Bioresorbable Vascular Scaffold Implantation in patients with Diabetes Mellitus - BVS-DM First

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 50 人待定

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
未指定
发起方
Erasmus MC, Universitair Medisch Centrum Rotterdam
入组人数
50
状态
尚未招募
最后更新
2年前

概览

简要总结

暂无简介。

注册库
who.int
开始日期
待定
结束日期
待定
最后更新
2年前
研究类型
Observational invasive

研究者

入排标准

入选标准

  • 1\. Patient is at least 18 years of age.
  • 2\. Patient is know with diabetes mellitus
  • 3\. Patient presenting with NSTEMI, stable or unstable angina , or silent ischemia caused by a de novo stenotic lesion in a native previous untreated coronary artery
  • 4\. Dmax (proximal and distal mean lumen diameter) within the upper limit of 3\.8 mm and the lower limit of 2\.0 mm by online QCA (at the moment only for the 2\.5 mm and 3\.5 mm devices)
  • 5\. The patient understands and accepts the meaning and the aims of the study
  • 6\. The patient is willing to comply with specified follow\-up evaluation and can be contacted by telephone (Signed Informed Consent)

排除标准

  • 1\. Previous CABG
  • 2\. Cardiogenic shock
  • 3\. STEMI patients requiring immediate stent implantation
  • 4\. Bifurcation lesion requiring kissing balloon postdilatation
  • 5\. Allergies or contraindications to antiplatelet medication or contrast material
  • 6\. Female patient with child bearing potential not taking adequate contraceptives or currently breasfeeding
  • 7\. Expected survival of \< 1 year

结局指标

主要结局

未指定

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