NCT00927940已完成不适用
The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent in De Novo Lesions in Native Coronary Arteries
Medtronic Vascular28 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2009年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 28
- 主要终点
- In-stent Late Lumen Loss (LLL)
研究概览
简要总结
The objective of the study is to verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent for the treatment of de novo lesions in native coronary arteries.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery
- •Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
- •Informed consent
- •Patient agrees to comply with specified follow-up evaluations at same investigational site
- •Single target lesion or two target lesions located in separate coronary arteries
- •De novo lesion(s) in native coronary artery(ies)
- •Target lesion(s) ≤ 27 mm in length
- •Target vessel(s) have reference vessel diameter 2.5 mm to 3.5 mm
排除标准
- •Within 7 days of implant platelet count <100,000 cells/mm³ or >700,000 cells/mm³; white blood cell (WBC) count <3,000 cells/mm³; serum creatinine level >2.5 mg/dl
- •Acute myocadial infarction (MI) within 72 hrs of the index procedure (Q wave myocardial infarction(QWMI) or any elevation of Creatinine Kinase Mycocardial-band Isoemzyme (CK-MB) > lab upper limit of normal)
- •Previous PCI of target vessel(s) within 9 months prior to the procedure
- •Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure
- •History of stroke or transient ischemic attack (TIA) within prior 6 months
- •Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
- •Inability to comply with required trial antiplatelet regimen
- •Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
- •Target vessel(s) has/have other lesions w/ > 40% diameter stenosis
- •Unprotected left main coronary artery disease
结局指标
主要结局
In-stent Late Lumen Loss (LLL)
时间窗: Post procedure, 8 Months
The difference between the post-procedure immediate minimal lumen diameter (MLD) and follow up angigraphy MLD
次要结局
- Percent of Patient With Target Lesion Failure(Major Secondary Endpoint)(12 months)
- Rates of Incomplete Stent Apposition, Neointimal Hyperplastic Volume and Percent Volume Obstruction (%VO)(8 months)
- Success(Device, Lesion, Procedure), Major Adverse Cardiac Events (MACE), Target Vessel Failure (TVF), and Stent Thrombosis(12 months)
研究者
研究点 (28)
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