NL-OMON33929
已完成
3 期
A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element*) for the Treatment of up to two De Novo Coronary Artery Lesions - PLATINUM
Boston Scientific Cooperation International0 个研究点目标入组 100 人待定
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Boston Scientific Cooperation International
- 入组人数
- 100
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Patient must be at least 18 years of age.
- •2\. Patient has documented stable angina pectoris (Canadian Cardiovascular Society \[CCS] Classification 1, 2, 3, or 4\) or documented silent ischemia; or unstable angina pectoris (Braunwald Class IB\-C, IIB\-C, or IIIB\-C
- •3\. Patient has a left ventricular ejection fraction (LVEF) \>\=30% as measured within 30 days prior to enrollment
- •4\. No more than 2 de novo target lesions in 2 separate native epicardial vessels may be treated, as described below under Multiple Interventions During Index Procedure. Multiple focal lesions may be treated if the lesions can be completely covered with 1 stent.
- •5\. No more than 1 de novo non\-target lesion in 1 non\-target vessel may be treated, as described below under Multiple Interventions During Index Procedure. Multiple focal lesions may be treated if the lesions can be completely covered with 1 stent.
- •6\. Target lesion must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) as follows:
- •o \>\=2\.50 mm and \<\=4\.25 mm for the RCT (WH selection criteria)
- •o \>\=2\.25 mm and \<2\.50 mm for the non\-randomized SV subtrial (SV selection criteria)
- •o \>\=2\.50 mm and \<\=4\.25 mm for the non\-randomized LL subtrial (LL selection criteria)
- •7\. Target lesion length must measure (by visual estimate):
排除标准
- •1\. Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI.
- •2\. Patient has had a known diagnosis of recent MI (ie, within 30 days prior to the index procedure) and has elevated enzymes at the time of the index procedure as follows.
- •o Patients are excluded if any of the following criteria are met at the time of the index procedure.
- •o If CK MB \>2× upper limit of normal (ULN), the patient is excluded regardless of the CK Total.
- •o If CK MB is 1 2× ULN, the patient is excluded if the CK Total is \>2× ULN.
- •o If CK Total/CK MB are not used and Troponin is, patients are excluded if the following criterion is met at the time of the index procedure.
- •o Troponin \>1× ULN with at least one of the following.
- •o Patient has ischemic symptoms and ECG changes indicative of ongoing ischemia (eg, \>1 mm ST segment elevation or depression in consecutive leads or new left bundle branch block \[LBBB]);
- •o Development of pathological Q waves in the ECG; or
- •o Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
结局指标
主要结局
未指定
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