NCT02133287Unknown不适用
A Prospective, Multi-center, Randomized Trial To Evaluate The Safety and Efficacy of 'AVI' Stent Comparing With Firebird2® For Treating Coronary Revascularization
Beijing AmsinoMed Medical Device Co., Ltd1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2013年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Ischemia-driven target lesion failure(iTLF), including cardiac death, target vessel related MI(Q wave and Non-Q wave) and ischemic-driven target lesion revascularization(iTLR)
研究概览
简要总结
To evaluate The Safety and Efficacy of 'AVI' Stent Comparing with Firebird2® For Treating Coronary Revascularization.
详细描述
The study is a Prospective, Open-lable, Multi-center, Randomized trial. 2000 primary coronary artery disease patients will be enrolled with a 1:1 randomization ratio(AVI:1000,Firebird 2:1000) at approximately 40 sites, Subject follow-up be at 30 days, 6 months, 9 months, 12 months, 2-5 years after procedure.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be at least 18 years of age.
- •Ischemic heart symptom and/or myocardial ischemia, include chronic stable/unstable coronary artery disease or acute coronary syndrome(ST elevated MI and Non-ST elevated MI)
- •At least one lesion diameter stenosis(DS) ≥70％, reference vessel diameter between ≥2.5mm, and ≤3.5mm.
- •If the subject has multiple vessel lesions, the implanted stents must be the same brand. The staged procedure only be allowed within 3 months after procedure, the implanted stent must be the same brand stent as the index procedure.
- •Subject has no CABG contraindication.
- •Subject or legal representative is informed the property of the study, understand the stipulations in the protocol, ensure the compliance and sign the ICF.
排除标准
- •Pregnant or nursing patients and those who plan to become pregnant up to 1 year post index procedure.
- •Subject has a tendency to bleeding or coagulation disorders, or has contraindication of antiplatelet and/or anticoagulant therapy, or can't accept the continue DAPT within 6 months.
- •Poor compliance or expectation of life less than 1 year.
- •Implanted any brand stent in the same target vessel within 1 year.
- •Left Ventricular Ejection Fraction (LVEF) of <30％
- •Cardiogenic shock or haemodynamics abnormal, needs inotropic agents or mechanical support.
- •The subject is allergic to asprin, heparin, clopidogrel/ticlopidine, stainless steel alloy, Arsenic trioxide, sirolimus, styrene-butene-styrene or polylactic acid(PLA) polymer and contrast agent.
- •Severe tortuous and/or heavy calcification lesion.
- •Two or more proximal chronic total occlusion lesion.
- •Bifurcation lesions with double stents.
- •The subject has multi vessel lesions but can not be implanted the same brand stents
- •The subject that the investigator considers he/she was unfit to implant the AVI stents and Firebird 2 stents.
- •The subject attended other drug/device study or in the follow-up period.
结局指标
主要结局
Ischemia-driven target lesion failure(iTLF), including cardiac death, target vessel related MI(Q wave and Non-Q wave) and ischemic-driven target lesion revascularization(iTLR)
时间窗: at 12 months post procedure
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral ArteryPeripheral Arterial DiseaseNCT03776799University of Leipzig120
已完成
不适用
A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary In-stent RestenosisCoronary In-stent RestenosisNCT03373695DK Medical Technology (Suzhou) Co., Ltd.260
终止
不适用
Bypass Surgery Versus Everolimus-Eluting Stent Implantation for Multivessel Coronary Artery Disease (BEST)Coronary Artery DiseaseNCT00997828Seung-Jung Park888
已完成
不适用
ABRE Clinical Study of the Abre Venous Self-expanding Stent SystemIliofemoral Venous ObstructionNCT03038438Medtronic Endovascular260
已完成
3 期
A Study Comparing the Efficacy and Safety of Intracoronary Stenting With or Without Abciximab, an Anti-Platelet Therapy, and Conventional Coronary Angioplasty With AbciximabAngioplasty, Transluminal, Percutaneous CoronaryNCT00271401Centocor, Inc.2,399