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 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,260
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
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;
- •11. A diabetic patient ;
- •12. Known renal insufficiency (e.g. serum creatinin level of more than 200 ìgram/L);
- •13. 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);
- •14. History of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days of randomization;
- •15. History of a hemorrhagic stroke at any time, or stroke or transient ischemic accident (TIA) of any etiology within 30 days of randomization;
- •16. Previous or scheduled chemotherapy or radiotherapy within 30 days prior or after the procedure;
- •17. On immune-suppression therapy or with known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
- •18. Severe hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure over 100 mmHg, after treatment)
- •19. Contraindication for treatment with the Genous™ EPC capturing stent, such as previous administration of murine therapeutic antibodies and exhibition of sensitization through the production of Human Anti-Murine Antibodies (HAMA).
- •20. Known hypersensitivity or contraindication to aspirin, heparin or clopidogrel;
- •21. Elective surgery, planned within the first 6 months after the procedure that requires discontinuing either aspirin or clopidogrel;
- •22. Previous heart transplant or any other organ transplant;
- •23. Previous participation in this study;
- •24. Circumstances that prevent follow-up (no permanent home or address, transient, etc.);
- •25. Women who are pregnant or who are of childbearing potential who do not use adequate contraception.
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