NCT00192881Unknown不适用
Stenting With or Without Coating Compared With Angioplasty in Non-benestent Disease. A Randomised Comparison of Optimal Balloon Angioplasty and Primary Implantation of Stents With and Without Drug Elution in Complex Coronary Lesions
适应症
试验速览
- 阶段
- 不适用
- 试验地点
- 2
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
- •Informed consent
- •Optimal result (< 35% residual stenosis and < type C dissection) after balloon angioplasty
- •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)
- •Exclusion criteria:
- •Other severe disease with an expected survival < 1 year
- •Other significant cardiac disease
- •Known allergy against paclitaxel, clopidogrel (or ticlopidine),
- •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
排除标准
- 未提供
研究者
研究点 (2)
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