跳至主要内容
临床试验/NCT00777842
NCT00777842终止不适用

Silencing the c-Myc Gene Using Third Generation Antisense Restenosis Therapy

Cook Group Incorporated1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2008年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
19
试验地点
1
主要终点
Vessel Lumen Patency

研究概览

简要总结

The GTX™ Drug Eluting Coronary Stent System is intended for the treatment of patients with a lesion in the coronary artery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient has discrete de novo lesion of a coronary artery with symptomatic ischemic heart disease
  • •Planned treatment of one lesion with a single stent
  • •Denovo type A, B1 lesions with a Reference diameter between 3.0 and 3.5mm and a lesion length between 5 and 16mm

排除标准

  • •Diabetic (HbA1C >6.0)
  • •Platelet count < 100000 cells/mm3 or > 700000 cells/mm3; WBC < 3000 cells/mm3; or a hemoglobin < 10 g/dl
  • •Renal dysfunction with creatinine > 2.0 mg/dl
  • •Patient has a known pre-dilatation ejection fraction (EF) less than forty five (<45%)
  • •Myocardial infarction (MI) less than 3 months prior to intervention
  • •Patient has type B2, C lesion
  • •Reference artery diameter <3.0 or >3.6 mm
  • •Target lesion length < 5mm and >16 mm
  • •Other stenosis >50% in target vessel
  • •Known hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine, or cobalt chromium, or a sensitivity to contrast agent that, in the opinion of the investigator, cannot be adequately premedicated.

研究组 & 干预措施

1

Experimental

Device

干预措施: GTX™ Drug Eluting Coronary Stent System (Device)

结局指标

主要结局

Vessel Lumen Patency

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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