NL-OMON27491
尚未招募
不适用
A randomized multi-center trial of elective revascularization with EPC capturing stenting versus bare metal stenting in patients with de novo coronary lesions with a low risk of coronary restenosis: The Genous™ EPC capturing stent versus a bare metal stent
Investigator initiated study, AMC-UvA0 个研究点目标入组 1,260 人待定
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- elective PCI, low risk of restenosis, endothelial progenitor cells, bare metal stent
- 发起方
- Investigator initiated study, AMC-UvA
- 入组人数
- 1260
- 状态
- 尚未招募
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Clinically stable patients undergoing a PCI for a coronary artery lesion with a low risk of restenosis are candidates for entry into this study.
- •A target lesion is considered to be at a low risk of restenosis if all of the following apply:
- •1\. A de novo lesion located in a native epicardial vessel with a Reference Vessel Diameter (RVD) greater than 2\.8 mm by visual estimation;
- •2\. A de novo lesion with a length of smaller than 20 mm by visual estimation;
- •3\. A de novo lesion with a TIMI flow equal to or greater than 1;
- •4\. The patient does not have diabetes mellitus
排除标准
- •1\. Younger than 18 years of age;
- •2\. A target lesion located in the left main coronary artery;
- •3\. A chronic, totally occluded (CTO) target lesion;
- •4\. A target lesion with involvement of a side branch, which is equal to or greater than 2\.0 mm in diameter by visual estimation;
- •5\. A restenotic target lesion;
- •6\. A target lesion in an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft;
- •7\. A target lesion(s) with an indication for treatment with a drug\-eluting stent (DES).
- •8\. Urgent need for revascularization;
- •9\. ST Elevation Myocardial Infarction (STEMI) within the past six weeks;
- •10\. Ventricular tachyarrhythmias within the past week;
结局指标
主要结局
未指定
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