NL-OMON28696
招募中
不适用
A randomized multi-center trial of elective revascularization with EPC capturing stenting versus drug eluting stenting in patients with de novo coronary lesions with a high risk of coronary restenosis: The Genous™ EPC capturing stent versus the paclitaxel or sirolimus eluting stent
Investigator-initiated study. AMC-UvA0 个研究点目标入组 1,300 人待定
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Investigator-initiated study. AMC-UvA
- 入组人数
- 1300
- 状态
- 招募中
- 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 native, de novo, coronary artery lesion(s), are candidates for entry into this study.
- •A target lesion is considered to be at a high risk of restenosis if one or more of the following apply:
- •1\. A chronic total occlusion;
- •2\. A lesion with a length equal to or greater than 20 mm;
- •3\. A lesion in a coronary artery vessel with a diameter equal to or smaller than 2\.8 mm (by visual estimation);
- •4\. Any lesion in a patient with diabetes mellitus (independent of lesion length or vessel diameter).
排除标准
- •1\. Younger than 18 years of age;
- •2\. Any target lesion located in the left main coronary artery;
- •3\. Any target lesion with involvement of a side branch, which is equal to or greater than 2\.0 mm in diameter by visual estimation;
- •4\. Any restenotic target lesion;
- •5\. Any target lesion in an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft;
- •6\. Urgent need for revascularization;
- •7\. ST Elevation Myocardial Infarction (STEMI) within the past six weeks;
- •8\. Ventricular tachyarrhythmias within the past week;
- •9\. Known renal insufficiency (e.g. serum creatinin level of more than 200 ìgram/L);
- •10\. Platelet count of less than 100,000 cells/ mm3 or more than 700,000 cells/ mm3, a WBC of less than 3,000 cells/ mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis);
结局指标
主要结局
未指定
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暂停
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