NCT00235092已完成4 期
A Prospective, Randomized, Multi-Center Comparison of the Cypher Sirolimus-Eluting and the Taxus Paclitaxel-Eluting Stent Systems.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,335
- 试验地点
- 1
- 主要终点
- The primary endpoint of the study is angiographic in-lesion binary restenosis rate at 8 months follow-up as determined by QCA.
研究概览
简要总结
The main objective of this study is to compare the performance of the Cypher sirolimus-eluting and the Taxus paclitaxel-eluting stent systems in a prospective, multi-center, randomized clinical study.
详细描述
This is a prospective, randomized study conducted at 90 centers in Europe, Latin-America and Asia. A total of 1335 patients will be entered into the study and will be randomized on a 1:1 basis to either the sirolimus-eluting or the paclitaxel-eluting stent system. All patients will have repeat angiography at eight months and will be followed for 24 months post-procedure.
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
- •Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II-III) OR patients with documented silent ischemia;
- •Treatment of up to two de novo native coronary artery lesions in a maximum of two major coronary arteries;
- •Ostial lesions;
- •Bifurcations;
- •Target vessel diameter of both lesions must be >=2.25mm and <=3.0mm in diameter (visual estimate);
- •One target lesion must be at least 15 mm in length and the second lesion has to be at least 10 mm in length with no upper limit on either;
- •Target lesion stenosis for both lesions is >50% and <100% (visual estimate).
排除标准
- •Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK >2 times normal within the preceding 72 hours and the CK and CK-MB enzymes remain above normal at the time of treatment;
- •Has unstable angina classified as Braunwald A I-II-III;
- •Any of the lesions is an unprotected left main coronary disease with >=50% stenosis;
- •Angiographic evidence of thrombus within target lesion;
- •Heavily calcified lesion and/or calcified lesion, which cannot be successfully predilated (applies to both lesions);
- •Documented left ventricular ejection fraction <=25%;
- •8. Totally occluded vessel (TIMI 0 level) (applies to both lesions);
- •9. Prior stent within 10mm of target lesion (applies to both lesions).
结局指标
主要结局
The primary endpoint of the study is angiographic in-lesion binary restenosis rate at 8 months follow-up as determined by QCA.
次要结局
未报告次要终点
研究者
研究点 (1)
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