ISRCTN74297220已完成不适用
TRI-stent Adjudication Study - High risk of Restenosis
Academic Medical Centre (AMC) (Netherlands)0 个研究点目标入组 1,300 人开始时间: 2007年7月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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 Percutaneous Coronary Intervention (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 revascularisation
- •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 creatinine level of more than 200 µgram/L)
- •10. Platelet count of less than 100,000 cells/mm^3 or more than 700,000 cells/mm^3, a White Blood Cell (WBC) count of less than 3,000 cells/mm^3, 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 randomisation
- •12. History of a haemorrhagic stroke at any time, or stroke or Transient Ischaemic Accident (TIA) of any aetiology within 30 days of randomisation
- •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 greater than 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 sensitisation 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 six 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
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