NCT01084408终止3 期
Randomized Trial on the Treatment of Coronary De-novo Lesions With a Drug Eluting Stent or a Drug Coated Balloon
University Hospital, Saarland4 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2010年3月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Late lumen loss
研究概览
简要总结
The aim of the trial is to assess the efficacy of the Paclitaxel-coated SeQuent®Please angioplasty balloon in the treatment of stenoses in native coronary arteries compared to a drug eluting stent.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Clinical evidence of stable or unstable angina or a positive functional study
- •Single, stenotic de novo lesion in a native coronary artery, type A or selected B1 (see 4.3.1.1 Definition of lesion types)
- •Diameter stenosis > 70% (visual estimate)
- •Vessel diameter 2.5 - 3.5 mm
- •Female patients can enter this study if they are post-menopausal for at least two years or have undergone hysterectomy or sterilization
- •Signed patient informed consent form
- •Patient's and treating physician's agree that the patient will return for all required post procedure follow-up assessments as defined in the clinical protocol
排除标准
- •Left ventricular ejection fraction of < 30%
- •Visible thrombus proximal to the lesion
- •Expection that treatment with devices other than PTCA will be required for this lesion.
- •Stenosis is within a bypass graft
- •Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, paclitaxel, or a sensitivity to contrast media which cannot be adequately pre-medicated
- •Other medical illness (i.e. cancer, liver disease or congestive heart failure) that may require cytostatic or radiation therapy, cause the subject to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than two years).
- •Acute myocardial infarction within the past 72 hours of the intended treatment (de-fined as: Q wave infarction having total creatinine kinase (CK) >3 times the upper normal limit, or CK remains elevated above hospital normal at time of treatment)
- •Chronic renal insufficiency with serum creatinine > 2.0 mg%
- •Significant gastrointestinal (GI) bleed within the past six months.
- •History of bleeding diathesis or coagulopathy or will refuse blood transfusions
- •Extensive peripheral vascular disease that precludes safe 6 French sheath insertion and / or requires additional anti-platelet and / or anti-coagulation treatment.
- •Participating in another device or drug study within the last 6 months which may inter-fere with the interpretation of results of this study
结局指标
主要结局
Late lumen loss
时间窗: 6 months
Late lumen loss = MLD in-lesion initially - MLD in lesion after six months (after nitroglycerin in identical projections); assessment by an independent Core Lab.
次要结局
- Thrombotic occlusion of the target lesion(30 days, 6, 12, 24, 60 months)
- Revascularization of the target lesion(30 days, 6, 12, 24, 60 months)
- Myocardial infarction(30 days, 6, 12, 24, 60 months)
- Death(30 days, 6, 12, 24, 60 months)
- Combined clinical endpoint (MACE)(30 days, 6, 12, 24, 60 months)
研究者
Bruno Scheller
MD
University Hospital, Saarland
研究点 (4)
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