A Prospective, Active Control Open Label, Multicentre Randomized Clinical Trial for Comparison Between BioMime Sirolimus Eluting Stent of Meril Life Sciences and Xience Everolimus Eluting Stent of Abbott Vascular Inc. to Evaluate Efficacy and Safety in Coronary Artery Disease.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 256
- 试验地点
- 30
- 主要终点
- To assess in-stent Late Lumen Loss
研究概览
简要总结
meriT-V is a Prospective,active control open lable clinical trial to compare safety & efficacy of BioMime Sirolimus stent Vs. Xience family of Everolimus stent by random assignment for treatment of coronary artery disease at multiple multinational centres.
详细描述
This study is conducted to evaluate the multicenter investigation comparing the BioMime Sirolimus Drug Eluting stent with XIENCE family of (Abbott Vascular, Santa Clara, California, USA) in the treatment of patients with coronary artery disease. Considering that the randomized studies provide a better comparability and a real efficacy and safety data of the devices. Subjects will be randomized 2:1 with surrogate endpoints and clinical evaluation.
Subject included in study are eligible to meet the inclusion and exclusion criteria of the study protocol .The informed consent process will be performed before the subject underwent for the Procedure. Subject will be treated with treatment allocated by the process of Randomization. The study follow up will be Seattle angina score evaluation up to 2 years after the procedure of angioplasty along with the Hospital or telephonic follow up at 1 Month 5month ,1 and 2 years and angiographic follow up at 9 Month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must be ≥18 years of age.
- •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
- •The patient has a planned intervention of up to two de-novo native lesions
- •Target lesion reference diameter ≥ 2.5 mm and ≤ 3.5 mm in diameter (visually estimated)
- •The target lesion length is less than or equal to 46 mm (visually estimated)
- •Patient willing to provide written informed consent.
- •If the patient is a female, she should be without childbearing potential who has undergone surgical sterilization or is post-menopausal.
- •The patient and the patient's physician agree to the follow-up visits including a 9 month angiographic follow-up.
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 Normal Limit.
- •The patient has a known hypersensitivity or contraindication to any of the requisite medications including aspirin, heparin, clopidogrel, prasugrel, ticagrelor, sirolimus, everolimus.
- •There is an untreated significant lesion of > 40% diameter stenosis remaining proximal or distal to the target site after the planned intervention.
- •Previous placement of any stent at the target lesion and/or within 10 mm of the target lesion.
- •Lesion with a significant side branch (branch diameter >2 mm) that would be covered by stenting
- •Total occlusion or TIMI 0 coronary flow in the target vessel.
- •Left Main coronary artery disease (stenosis >50%)
- •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 patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
- •The patient suffered a stroke, transient ischemic neurological attack (TIA) or significant gastrointestinal (GI) bleed within the past 6 months
- •The patient has renal insufficiency as determined by a creatinine of > 2.0mg/dl or 180 µmol/l.
- •The target lesion, or the target vessel proximal to the target lesion contains thrombus
- •Documented left ventricular ejection fraction of ≤30%
- •The patient is a recipient of a heart transplant
- •The patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion or extreme angulations of the vessel at accesslocation (< 45 degrees)
- •The patient has other medical illness (i.e., 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 (i.e., less than one year)
- •The patient is simultaneously participating in another investigational device or drug study
研究组 & 干预措施
Sirolimus Eluting Coronary Stent
BioMime Sirolimus Eluting Stent of Meril Life Sciences
干预措施: Sirolimus Eluting Coronary Stent (Device)
Everolimus-eluting Coronary stent
XIENCE family (V, Xpedition or Prime) of Everolimus-eluting stent system of Abbott Vascular Inc.
干预措施: Everolimus-eluting Coronary stent (Device)
结局指标
主要结局
To assess in-stent Late Lumen Loss
时间窗: 9 months
The primary outcome of this study is to assess in-stent Late Lumen Loss at 9 months for both treatment strategies.
次要结局
- Clinical Evaluation(1, 5, 9, 12 and 24 months)
- Frequency of Binary restenosis by Angiography(9 months)
- In-segment Late Lumen Loss at 9 months(9 months)
- Minimum Lumen Diameter by Angiography(9 months)