NCT00623441已完成不适用
E-Five Registry: To Evaluate the 'Real World' Clinical Performance of the Medtronic Endeavor ABT-578 Eluting Coronary Stent System; A Prospective, Multicenter Registry
Medtronic Bakken Research Center0 个研究点目标入组 8,314 人开始时间: 2005年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8,314
- 主要终点
- MACE (Major Adverse Cardiac Events)
研究概览
简要总结
The safety and efficacy of the Endeavor(TM) ABT-578 Eluting Coronary Stent System has been assessed in a series of studies. The stent is coated with a proprietary drug compound that is designed to reduce restenosis.
This prospective multi-center study has been initiated:
- To document the acute and mid-term safety and overall clinical performance of the stent system in a "real world" patient population requiring stent implantation.
- To assess the event rate in patient subgroups with specific clinical indications and/or vessel or lesion characteristics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 >18 years of age (or minimum age as required by local regulation)
- •The patient has consented to participate by signing the "Patient Informed Consent Form" and/or has authorized the collection and release of his medical information by signing the "Patient Data Release Consent Form".
- •The patient is suitable for implantation of one or more Endeavor(TM) ABT-578 Eluting Coronary Stent System in one or more native artery target lesions.
- •Lesion length and vessel diameter of the target lesion(s) are according to the "Indications for Use" as mentioned in the "Instructions for Use" that comes with every Endeavor(TM) ABT-578 Eluting Coronary Stent System.
- •The patient is willing and able to cooperate with registry procedures and required follow up visits.
排除标准
- •Women with known pregnancy or who are lactating.
- •Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drugs such as ABT-578, rapamycin, tacrolimus, sirolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.
- •Patients in whom anti-platelet and/pr anticoagulation therapy is contraindicated.
- •Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.
- •Current medical condition with a life expectancy of less than 12 months.
- •The subject is participating in another device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this trial. The subject may only be enrolled in this E-five registry once.
- •Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this registry.
结局指标
主要结局
MACE (Major Adverse Cardiac Events)
时间窗: 12 Months
MACE is defined as death, myocardial infarction (Q-wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization (repeat PTCA (Percutaneous Transluminal Coronary Angioplasty) or CABG (Coronary Artery Bypass Graft surgery))
次要结局
未报告次要终点
研究者
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