NCT00777842终止不适用
Silencing the c-Myc Gene Using Third Generation Antisense Restenosis Therapy
适应症
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.
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
研究点 (1)
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