A Prospective, Randomized, Multi-Center Comparison of the Cypher Sirolimus-Eluting and the Taxus Paclitaxel-Eluting Stent Systems.

Cordis Corporation1 个研究点分布在 1 个国家目标入组 1,335 人2003年8月

适应症Coronary Artery Disease

概览

阶段: 4 期
干预措施: 未指定
疾病 / 适应症: Coronary Artery Disease
发起方: Cordis Corporation
入组人数: 1335
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.
状态: 已完成
最后更新: 19年前

概览研究者入排标准结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2003年8月

结束日期

2006年3月

最后更新

19年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Cordis Corporation

入排标准

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%;
•Totally occluded vessel (TIMI 0 level) (applies to both lesions);
•Prior stent within 10mm of target lesion (applies to both lesions).