NL-OMON35665
已完成
4 期
A Prospective, Randomized, Multi-center Trial to Assess the Everolimus-Eluting Coronary Stent System (PROMUS Element) for Coronary Revascularization in a Population of Unrestricted Patients - PLATINUM-PLUS
European Cardiovascular Research Center CERC0 个研究点目标入组 100 人待定
概览
- 阶段
- 4 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Coronary artery disease
- 发起方
- European Cardiovascular Research Center CERC
- 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\. The patient must be \>\=18 of age
- •2\. Symptomatic ischemic heart disease (CCS class 1\-4, Braunwald Class IB, IC, and/or objective evidence of myocardial ischemia);
- •3\. Acceptable candidate for CABG;
- •4\. The patient is willing to comply with specified follow\-up evaluations;
- •5\. The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics Committee (MEC).
- •6\. Single or multiple native coronary artery or saphenous vein graft lesions in single or multiple vessels;
- •7\. Patients with multi\-lesion or multi\-vessel coronary disease may undergo staged (planned) procedures within 42\-days of the index procedure.
- •8\. Reference vessel diameter must be \>\=2\.25 to \<\= 4\.25 mm by visual estimate.
排除标准
- •1\. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child\-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test;
- •2\. Patients in whom anti\-platelet and/or anticoagulant therapy is contraindicated;
- •3\. Patient has other medical illness (e.g., cancer, known malignancy , congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non\-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year);
- •4\. Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, prasugrel, platinum chromium alloy, everolimus, and/or contrast sensitivity that cannot be adequately pre\-medicated;
- •5\. Patient with LVEF \<20%, cardiogenic shock, or hemodynamic compromise requiring pressors or inotropes or mechanical support devices
- •6\. Any significant medical condition which in the Investigator\*s opinion may interfere with the patient\*s optimal participation in the study;
- •7\. Currently participating in another investigational drug or device study.
结局指标
主要结局
未指定
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