NCT00151658已完成不适用
Randomized Multicenter Comparison of Sirolimus Versus Bare Metal Stent Implantation in Complex Coronary Lesions. Acronym: Scand Stent
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 322
- 试验地点
- 2
- 主要终点
- Minimal lumen diameter
研究概览
简要总结
The purpose of this study is to evaluate the clinical and angiographic outcome of implantation of stents eluting or not eluting Sirolimus in patients with complex coronary artery lesions suitable for percutaneous coronary intervention.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable, or unstable angina and/or objective signs of myocardial ischaemia Lesions should be de novo and located in native vessels with a diameter > 2.25 mm.
- •Complex lesions to be included should have at least one of the following characteristics:
- •Ostial in location (< 5 mm from ostium)
- •Total occlusions with a length ≥ 15 mm
- •Bifurcational (side branch > 1.75 mm in diameter)
- •Angulated (> 45° within lesion)
排除标准
- •Other severe disease with an expected survival < 1 year
- •Other significant cardiac disease
- •Known allergy against paclitaxel, clopidogrel or stainless steel.
- •Myocardial infarction within 3 days of the index procedure
- •Linguistic difficulties needing an interpreter
- •Renal insufficiency (p-creatinine > 200 micromol/l)
- •Gastrointestinal bleeding within 1 month
- •Childbearing potential or pregnancy
- •Participation in another study
- •Unprotected left main disease
- •Restenosis
- •Lesions containing visible thrombus
- •Treatment with other modality than balloon or stent (ablation, brachytherapy, ultrasound) in connection with the index procedure
- •Diffuse coronary disease distal to the treated lesion
- •Heavily calcification
- •Lesion located in saphenous vein graft
结局指标
主要结局
Minimal lumen diameter
Frequency of restenosis (>50%) at 6 months.
次要结局
- Diameter stenosis, late loss and loss index at 6 months MACE: death, myocardial infarction, target lesion revascularisation within 12 months and 24 months
研究者
研究点 (2)
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