ACTRN12608000072314招募中未知
Bare Metal Bifurcation Stent Clinical Trial in Humans (IP088) - Safety at 30 Days
Medtronic Vascular0 个研究点目标入组 60 人开始时间: 2008年2月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 /A（—）
- 性别
- All
入选标准
- •Patient is =/> 18 years old
- •Acceptable candidate for Percutaneous Coronary Intervention (PCI) and Coronary Artery Bypass Graft (CABG)
- •Clinical evidence of ischemic heart disease
- •Female patients with negative pregnancy test
- •Informed Consent Obtained
- •Agrees to comply with follow-up evaluations
- •Single de novo bifurcation lesion in a native coronary artery with specific dimensions
- •Stenosis =/> 50% and < 100%
- •Thrombolysis in Myocardial Infarction (TIMI) flow =/> 2
排除标准
- •Hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, chromium, molybdenum
- •Platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3
- •WBC < 3,000 cells/mm3
- •Serum creatinine level > 170 micromol/L
- •Evidence of MI within 72 hours of intended trial procedure
- •Previous stenting in Target Vessel
- •LVEF < 30%
- •History of stroke or TIA within 6 months
- •History of bleeding diathesis or coagulopathy or refusal of blood transfusion
- •Specific target lesion morphology
研究者
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