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 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,300
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 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);
- •11. History of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days of randomization;
- •12. History of a hemorrhagic stroke at any time, or stroke or transient ischemic accident (TIA) of any etiology within 30 days of randomization;
- •13. Previous or scheduled chemotherapy or radiotherapy within 30 days prior or after the procedure;
- •14. On immune-suppression therapy or with known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.);
- •15. Severe hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure over 100 mmHg, after treatment);
- •16. 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);
- •17. Contraindication(s) for treatment with the PES or SES;
- •18. Known hypersensitivity or contraindication to aspirin, heparin or clopidogrel;
- •19. Elective surgery, planned within the first 6 months after the procedure that requires discontinuing either aspirin or clopidogrel;
- •20. Previous heart transplant or any other organ transplant;
- •21. Previous participation in this study;
- •22. Circumstances that prevent follow-up (no permanent home or address, transient, etc.);
- •23. Women who are pregnant or who are of childbearing potential who do not use adequate contraception.
研究者
相似试验
尚未招募
不适用
TRI-stent Adjudication Study - Low risk of Restenosiselective PCI, low risk of restenosis, endothelial progenitor cells, bare metal stentNL-OMON27491Investigator initiated study, AMC-UvA1,260
已完成
不适用
Multicenter trial of elective revascularization in patients with diabetes mellitus and mild anginal complaintsDiabetes Mellitus type II (DM type II), Coronary artery diseaseNutritional, Metabolic, EndocrineNon-insulin dependent diabetesISRCTN65663256Academic Medical Centre (AMC) (Netherlands)800
暂停
不适用
Multicenter trial of elective revascularization in patients with diabetes mellitus and mild anginal complaints.NL-OMON20816* The Netherlands Heart Foundation (NHS)* The Netherlands Organisation for Health Research and Development (ZonMw)800
进行中（未招募）
Unknown
Randomised controlled multi centre trial comparing two standard of care revascularisation treatments, either percutaneous angioplasty and stents (PCI) or coronary artery bypass grafting (CABG), in patients who have been diagnosed with a condition that reduces heart function known as ischaemic left ventricular dysfunction (ilSVD) as well as coronary artery disease (CAD)Circulatory SystemHeart failureISRCTN29654606niversity of Leicester630
招募中
不适用
Multicenter prospective randomized study of surgical ablation for atrial fibrillation during non-mitral cardiac operatioatrial fibrillationJPRN-UMIN000016129The Cardiovascular Institute Academic Research Organization400