CTRI/2009/091/000347Other4 期
A randomized comparison of the Supralimus(R) stent with the Xience V(TM) stent in the treatment of patients with de novo native coronary artery lesions
Sahajanand Medical Technologies Pvt Ltd0 个研究点目标入组 360 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- Other
- 发起方
- 入组人数
- 360
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
- •1. Age greater than or equal to 18 years.
- •2. Eligible for percutaneous coronary intervention (PCI)
- •3. Acceptable candidate for CABG
- •4. Clinical evidence of ischemic heart disease and/or a positive territorial functional study. Documented stable angina pectoris ((Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C or IIIB-C), or documented silent ischemia.
- •5. The target lesion is a single de novo coronary artery lesion with greater than or equal to 50% and < 100% stenosis in one of the major epicardial territories (LAD, LCX or RCA). A second target lesion in another major epicardial vessel could be treated and this second lesion should fit with the inclusion/exclusion criteria and will receive the same type of stent.
- •6. The target lesion must be covered by one study stent, preferably with a margin of 3 mm on each side of the lesion.
- •7. The target lesion must be less than or equal to 22 mm in length by visual estimate.
- •8. The target reference vessel diameter must be greater or equal to 2.5 mm and less or equal to 3.5 mm.
- •9. Patient or patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the clinical site.
排除标准
- •1. Female of childbearing potential
- •2. Documented left ventricular ejection fraction (LVEF) less than or equal to 30%
- •3. Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure
- •4. Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®, Ceruvin) or ticlopidine (Ticlid®), heparin, sirolimus, everolimus, stainless steel, cobalt, chromium, contrast agent (that cannot be adequately pre-medicated)
- •5. A platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC <3,000 cells/mm3
- •6. Acute or chronic renal dysfunction (creatinine >2.0mg/dl or >150µmol/L)
- •7. Total occlusion (TIMI 0) or TIMI 1
- •8. Target vessel has evidence of thrombus
- •9. Target vessel is excessively tortuous which makes it unsuitable for proper stent delivery and deployment
- •10. Previous bare metal stenting (less than 1 year) anywhere within the target vessel
- •11. Previous drug-eluting stenting anywhere within any epicardial vessel
- •12. The target lesion requires treatment with a device other than PTCA prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.)
- •13. Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run-off
- •14. Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated
- •15. Target lesion is located in or supplied by an arterial or venous bypass graft
- •16. Ostial target lesion
- •17. Target lesion involves a side branch >2.0mm in diameter with an ostial disease
- •18. Patient is currently participating in an investigational drug or device study, including its follow-up period
- •19. Within 30 days prior to procedure, patient has undergone a previous coronary interventional procedure of any kind
- •20. Within 60 days post-procedure, patient requires planned interventional treatment of any non-target vessel. Planned intervention of the target vessel after the index procedure is not allowed.
- •21. Stroke or transient ischemic attack within the prior 6 months
- •22. Unprotected Left Main (LM) coronary artery disease (stenosis >50%)
- •23. In the investigator's opinion, patient has a co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
- •24. Planned surgery within 6 months after the index procedure
- •25. Life expectancy less than 1 year
研究者
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