NCT00248079已完成1 期
The Clinical Response Evaluation of the Medtronic Endeavor CR ABT-578 Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions
Medtronic Vascular1 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2005年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Late lumen loss (in-stent) as measured by quantitative coronary angiography (QCA)
研究概览
简要总结
To evaluate the clinical safety, efficacy, and pharmacokinetics (PK) of the Endeavor Resolute Zotorolimus Eluting Coronary Stent System for the treatment of single de novo lesions in native coronary arteries with a reference vessel diameter (RVD) between 2.5 and 3.5 mm in diameter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is at least 18 years old
- •Patient is an acceptable candidate for percutaneous coronary intervention and emergent coronary artery bypass graft surgery
- •Patient has clinical evidence of ischemic heart disease or a positive functional study
- •Female patients of childbearing potential must have a negative pregnancy test within 7 days before the trial procedure
- •Patient or patient's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by Human Research Ethics Committee of the respective investigational site
- •Patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed. Patients participating in the PK sub-study must agree to the additional follow-up procedures as required by the sub-study
排除标准
- •Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, chromium, molybdenum, polymer coating components or a sensitivity to contrast media, which cannot be adequately pre-medicated
- •History of an allergic reaction or significant sensitivity to drugs such as ABT-578, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
- •Platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (WBC) count < 3,000 cells/mm³
- •Serum creatinine level > 170 micromol/L within 7 days prior to index procedure
- •Evidence of an acute myocardial infarction within 72 hours of the intended trial procedure (defined as: Q wave myocardial infarction or non-Q wave myocardial infarction having CK enzymes > 2X the laboratory upper limit of normal with the presence of an elevated CK-MB (any amount above the laboratory upper limit of normal))
- •Previous stenting anywhere in the target vessel
- •PCI of the target vessel within 30 days prior to the procedure
- •Implantation of a drug eluting stent in any non-target vessel within 30 days prior to the procedure. Implantation of a Cypher stent in any non-target vessel within 90 days prior to the procedure
- •PCI of a non-target vessel with a bare metal stent within 30 days prior to the procedure that results in any MACE event. If the bare metal stent is implanted within 72 hours prior to the procedure, a post procedural serial CK or CK-MB measurement above the investigational site's upper limit of normal (two below upper normal required for enrollment)
- •PCI of a non-target vessel within 24 hours prior to the procedure
- •Planned PCI of any vessel within 30 days post-procedure. Planned stenting of any vessel with a Cypher or Endeavor stent within 60 days post-procedure
- •Planned PCI of the target vessel within 9 months post-procedure
- •During the index procedure, the target lesion requires treatment with a device other than PTCA prior to stent placement
- •History of a stroke or transient ischemic attack within the prior 6 months
- •Active peptic ulcer or upper gastrointestinal bleeding within the prior 6 months
- •History of bleeding diathesis or coagulopathy or will refuse blood transfusions
- •Concurrent medical condition with a life expectancy of less than 12 months
- •Any previous or planned treatment of the target vessel with anti-restenotic therapies including, but not limited to brachytherapy
- •Currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures
- •Documented left ventricular ejection fraction < 30% at the most recent evaluation
结局指标
主要结局
Late lumen loss (in-stent) as measured by quantitative coronary angiography (QCA)
时间窗: 9 months
次要结局
- Major adverse cardiac event (MACE) rate(30 days, 4, 6, 9 & 12 months)
- Acute success (device, lesion, and procedure)(4 or 9 Months)
- Target vessel failure (TVF)(9 months)
- Target lesion revascularization (TLR)(9 months)
- Neointimal hyperplastic volume and percent volume obstruction (%VO) as measured by intravascular ultrasound (IVUS)(4 or 9 months)
- Pharmacokinetic parameters(last measurement at 60 days)
- Angiographic parameters (in-stent and in-segment)(4 or 9 months)
研究者
研究点 (1)
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