ACTRN12611001131943已完成1 期
Evaluating the Svelte Drug Eluting Stent-on-a-Wire (DESOAW) in Patients with Symptomatic Ischemic Heart Disease due to Coronary Artery Blockage
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Patient is at least 18 years old;
- •2. Patient is eligible for percutaneous coronary intervention (PCI) and an acceptable candidate for emergent coronary artery bypass graft (CABG) surgery;
- •3. Patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, and/or a positive functional study;
- •4. Patient has either a single target lesion, or two lesions (target and non-target) located in separate coronary arteries;
- •5. Reference vessel of 2.5 mm through 3.5 mm in diameter by visual estimate;
- •6. Target lesion less than 20 mm in length by visual estimate (the intention should be to cover the whole lesion with one stent of adequate length);
- •7. Target lesion stenosis between 50% and 100% by visual estimate.
排除标准
- •1. Patient is currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints;
- •2. The patient requires a staged procedure of the target vessel within 6 months or a staged procedure of a non-target vessel within 30 days post-procedure;
- •3. The target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.);
- •4. Any DES deployment anywhere in the target vessel within the past 9 months;
- •5. Any BMS deployment anywhere in the target vessel within the past 6 months;
- •6. Any previous stent placement within 10 mm (proximal or distal) of the target lesion;
- •7. Myocardial infarction within 72 hours of the index procedure, with the exception of:
- •a. Patients who have had a STEMI and PCI to the culprit lesion may be included if they have a suitable lesion in another vessel, and have been clinically and hemodynamically stable for 72 hours;
- •b. Patients who have had a non- STEMI may be included if their CK is within the laboratory normal range within 24 hours pre-procedure.
- •8. Co-morbid condition(s) that could limit the patient’s ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial;
- •9. Concurrent medical condition with a life expectancy of less than 12 months;
- •10. Documented left ventricular ejection fraction (LVEF) of at least 30%;
- •11. Unstable angina pectoris from an extra-cardiac cause (Braunwald Class A I-III);
- •12. Known allergies to the following: Acetylsalicylic acid (ASA), Clopidogrel bisulfate, Ticlopidine, Prasugrel, Rapamycin, PEAIII AcBz, Heparin/ Bivalirudin, or contrast agent (that cannot be adequately premedicated);
- •13. Platelet count = less than100,000 cells/mm3 or greater than 700,000 cells/mm3 or a WBC less than 3.000 cells/mm3 or hemoglobin less than 100g/l;
- •14. Acute or chronic renal dysfunction (serum creatinine greater than 170µmol/L);
- •15. History of a stroke or transient ischemic attack (TIA) within the prior 6 months;
- •16. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months;
- •17. History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- •18. Patients requiring ongoing anticoagulation with warfarin or dabigatran.
- •19. Total occlusion (TIMI 0 or 1);
- •20. Target vessel has angiographic evidence of thrombus
- •21. Target vessel is excessively tortuous or has heavy calcification;
- •22. Significant ( greater than 50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off;
- •23. Target lesion is located in or supplied by an arterial or venous bypass graft;
- •24. Ostial target lesion (within 5.0mm of vessel origin) or any location within the left main coronary artery;
- •25. Target lesion involves a side branch greater than 2.0mm in diameter;
- •26.Unprotected Left main coronary artery disease (stenosis greater than 50%).
研究者
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