NCT00225693已完成不适用
ELUTES III - V-Flex Plus PTX Drug Eluting Coronary Stent
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Evaluation by IVUS of % diameter stenosis at follow up.
研究概览
简要总结
The study is intended to collect data to evaluate effectiveness and safety of drug eluting stent devices in a dose ranging assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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 must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery.
- •Patient must be an acceptable candidate for coronary artery bypass surgery
- •Patient or legal guardian must have given informed consent
- •Patient agrees to return at one month for an office visit to assess cardiovascular status and at 6 months for an office visit to assess cardiovascular status, an IVUS examination and a diagnostic angiogram.
排除标准
- •Patient must be less than 18 years old
- •Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- •Patient is simultaneously participating in another investigative interventional cardiovascular device or drug study.
- •Patient has known hypersensitivity or contraindication to aspirin, clopidogrel, or stainless steel, or a sensitivity to contrast dye.
- •Women of child bearing potential.
- •Patient has other medical condition that any cause non-compliance with the protocol, confound the results or is associated with limited life expectancy.
结局指标
主要结局
Evaluation by IVUS of % diameter stenosis at follow up.
次要结局
- Major adverse events
- Target lesion revascularization
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
In Stent ELUTES StudyCoronary Artery DiseaseNCT00225680Cook Group Incorporated124
已完成
不适用
Medtronic RevElution TrialCoronary Artery DiseaseNCT02480348Medtronic Vascular109
已完成
不适用
XLIMus Drug Eluting Stent: a randomIzed Controlled Trial to Assess EndothelizationCoronary Artery DiseaseNCT03745053Cardionovum GmbH180
已完成
4 期
Excel Drug-Eluting Stent Pilot Clinical RegistryCoronary StenosisNCT00385905JW Medical Systems Ltd100
已完成
不适用
XIENCE Xpedition Everolimus-Eluting Coronary Stent Japan Post Marketing Surveillance (XIENCE Xpedition SV Japan PMS)Ischemic Heart DiseaseMyocardial IschemiaCoronary Artery DiseaseAngina PectorisNCT02513732Abbott Medical Devices100