jRCT1080223575已完成2 期
An Exploratory Clinical Trial of Cilostazol Eluting Stent System (CES-1) in De Novo Coronary Artery Lesions
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- efficacy
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multicenter, Non-masking, Single group
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Clinical inclusion criteria
- •Patients who have evidence of myocardial ischemia confirmed by subjective symptoms (chest pain etc.), ST change in the electrocardiogram or objective findings.
- •Angiographic inclusion criteria
- •Single de novo lesion in native coronary arteries.
- •Target vessel diameter is 2.75 mm to 3.25 mm.
- •TIMI flow is 2 or more.
- •Angiographic percent diameter stenosis (by visual estimation) is 75% or more in AHA classification.
排除标准
- •Clinical exclusion criteria
- •Acute myocardial infarction Patients whose CK-MB or troponin exceeds the facility reference upper limit and have at least one of the following is confirmed are excluded as acute myocardial infarction.
- •i. Ischemic symptoms and Electrocardiographic findings showing continuous ischemia (eg, ST segment elevation or depression above 1 mm in contiguous leads, or the appearance of a new left bundle branch block).
- •ii. Pathological Q waves on electrocardiogram.
- •iii. Myocardial necrotic focus or wall motion abnormality newly confirmed in diagnostic imaging.
- •Patients who cannot be given emergency coronary artery bypass grafting (CABG).
- •Patients who cannot be administered antiplatelet drugs. The following cases are conceivable.
- •i. Significant intracranial hemorrhage, gastrointestinal bleeding, urinary tract hemorrhage etc. within the last 6 months.
- •ii. Surgical operation is planned that requires discontinuation of DAPT after the procedure.
- •iii. Anticoagulation therapy is underway and the risk of bleeding is high.
- •Bleeding tendency due to hemorrhagic diathesis or blood coagulation disorder.
- •Left ventricular ejection fraction (LVEF) is less than 30% within 30 days before the trial registration.
- •Renal dysfunction (Creatinine value exceeds 2.0 mg/dl or in case artificial dialysis).
- •Allergy to cobalt chrome alloy or contrast agent.
- •Patients who are participating in or will planning to participate in other clinical studies that may have clinical implications for the evaluation of this trial.
- •Patients who are pregnant or breast feeding.
- •Patients who are taking Cilostazol.
- •In cases where the Investigator determines that the patient's participation in the trial is inappropriate.
- •Angiographic exclusion criteria
- •Lesion in left main coronary trunk.
- •Lesion within 5 mm from the ostium right coronary art.
- •Lesion within 5 mm from the ostium left anterior descending/the ostium left circumflex branch.
- •Bifurcation lesion.
- •Within 1 year after implementing PCI on the target vessel or its branch.
- •There are other lesions that require PCI at the time of the procedure.
- •Type C of ACC/AHA classification.
结局指标
主要结局
efficacy
时间窗: 9 months
In-segment late lumen loss as measured by quantitative coronary angiography (QCA)
次要结局
- Device Success rate(Immediate post-procedure)
- Procedure success rate(At the time of hospital discharge)
- Patient Oriented Composite End point (POCE)(9 Months)
研究者
研究点 (1)
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