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A Prospective, Active control, open label, Multicentre Randomized Clinical Trial for comparison between BioMime Sirolimus Eluting Stent, or Meril Life Sciences and Xience Everolimus Eluting stent or Family of Abbott Vascular Inc.. to Evaluate Efficacy and Safety in Coronary Artery Disease - Merit - V
Meril Life Sciences Pvt. Ltd.0 个研究点目标入组 48 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
- 已完成
- 发起方
- 入组人数
- 48
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
- 年龄范围
- 18 至 99（—）
入选标准
- •* The subjects must be >= 18 years of age.
- •* Clinical evidence of ischemic heart disease and / or a positive territorial functional study.
- •- Documented stable angina (Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4 )
- •- Documented unstable angina with documented ischemia (Braunwald Class IB-C, C-IIB, IIIB or C),
- •- Documented silent ischemia
- •* The subject having a planned intervention or up to two de novo native lesions
- •* Target lesion reference diameter >= 2.5 mm and <= 3.5 mm (visually estimated)
- •* The target lesion length is less than or equal to 46 mm (visually estimated)
- •* Subjects willing to providence written informed consent.
- •* Female subjects without childbearing potential who have either undergone surgical sterilization or is postmenopausal.
- •* The subject and the subject's physician agree to the follow-up visits-including a 9 month angiographic followup.
排除标准
- •* Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours Preceding the index procedure, Unless the CK and CK-MB enzymes are less than twice the Upper Limit Normal.
- •* The subjects who have a known hypersensitivity or contraindication to any of the requisite medications including aspirin, heparin, clopidogrel, prasugrel, ticagrelor, sirolimus, everolimus or the contrast media
- •* There is an untreated significant lesion or> 40% diameter stenosis proximal or distal to the remaining target site after the planned intervention.
- •* Previous PCI with stent placement or any at the target lesion and / or within 10 mm of the target lesion.
- •* Lesion with a significant side branch (branch diameter > 2 mm) thatwould be covered by Stenting
- •* Total occlusion or coronary TIMI 0 flow in the target vessel.
- •* Left main coronary artery disease.
- •* The proximal target vessel or target lesion is severely calcified by visual assessment.
- •aorto-ostial * location, unprotected left main lesion location, or a lesion within 5 mm of the origin of the LAD or LCX.
- •* The subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
- •* The subject Suffered a stroke, transient ischemic neurological attack (TIA) or significant gastrointestinal (GI) bleeds within the past 6 months
- •* The subject has renal insufficiency as Determined by a creatinine of> 2mg/dl or 180 mg / dl.
- •* The target lesion, or the target vessel proximal to the target lesion contains thrombus
- •* Documented left ventricular ejection fraction of <= 30%
- •* The subject is a recipient of a transplant surgery (Heart, Kidney, Liver etc)
- •* The patient has extensive peripheral vascular disease That precludes safe 6 French sheath insertion
- •* Extreme angulations of the vessel at access location (<45 degrees)
- •* The subject has other medical illness (zoals cancer or congestive heart failure) That May cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with limited life expectancy (ie less than one year)
- •* The patient is simultaneously participant participating in another investigational drug or device study.
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