NCT01556126已完成不适用
Prove ART (Abluminal Reservoir Technology) Clinical Benefit in Alla Comers Patients
CID - Carbostent & Implantable Devices23 个研究点 分布在 6 个国家目标入组 1,191 人开始时间: 2012年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,191
- 试验地点
- 23
- 主要终点
- Clinical composite endpoint: Cardiac death/Target vessel MI/Clinically indicated TLR
研究概览
简要总结
The aim of this study is to evaluate safety and efficacy performances of CRE8 Drug Eluting Stent, in patients comparable to the everyday's clinical practice population, with a specific focus on diabetics, that will be part of a pre-specified study subgroup.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age > 18 years;
- •Patients with symptoms of stable angina or documented silent ischemia;
- •Patient with coronary artery disease ranging between 0 and 22 according to the Syntax score;
- •Patients with acute coronary syndrome, including unstable angina, NSTEMI and STEMI;
- •Patient is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for surgical revascularization (CABG);
- •Left ventricular ejection fraction > 30%;
- •Target de-novo lesions with diameter stenosis > 50% (including total occlusion);
- •Target lesion located in a target vessel with a diameter ranging from 2.5 to 4.0 mm;
- •Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site.
排除标准
- •Female with childbearing potential or lactating;
- •Known allergies to antiplatelets, anticoagulants, contrast media, sirolimus or cobalt chromium;
- •Acute or chronic renal dysfunction (defined as creatinine greater than 2.5 mg/dl or on dialysis);
- •Thrombocytopenia (platelet count less than 100,000/mm³) or hypercoagulable disorder;
- •Known significant gastro-intestinal or urinary bleeding within the past 6 months;
- •Patient refusing blood transfusion;
- •Patient currently under immunosuppressant therapy;
- •Patient with planned surgery within 6 months from the index procedure unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
- •Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year;
- •Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;
- •Patient underwent target vessel revascularization with a DES within 3 months prior to the index procedure;
- •Target lesion is located or supplied by an arterial or venous bypass graft.
研究组 & 干预措施
Amphilimus eluting stent (Cre8)
Experimental
Sirolimus formulated coronary eluting stent
干预措施: Amphilimus Eluting Stent (CRE8) (Device)
结局指标
主要结局
Clinical composite endpoint: Cardiac death/Target vessel MI/Clinically indicated TLR
时间窗: 6 months
次要结局
- Angiographic in-stent and in-segment endpoints (in the first 100 patients included in the pre-specified diabetic subgroup).(At 6 months)
- Clinical composite endpoints: - Cardiac death/Target vessel MI/Clinically indicated TLR - All death/All MI/All Repeat Revascularization(At 30 days, 1 year and yearly up to 5 years)
- Stent thrombosis(within 24 hours, 1 month, 6 months, 1 year and yearly up to 5 years)
研究者
研究点 (23)
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