NCT02542007已完成不适用
RECOVERY: A Prospective, Multi-center, Randomized Controlled Trial Evaluating the Safety and Efficacy of the Combo Bio-engineered Sirolimus-eluting Stent Versus the Nano Polymer-free Sirolimus-eluting Stent in the Treatment of Patients With de Novo Stenotic Lesions of Native Coronary Artery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- OrbusNeich
- 入组人数
- 440
- 试验地点
- 15
- 主要终点
- In-segment late lumen loss (LLL)
研究概览
简要总结
To evaluate the safety, efficacy and deliverability of the Combo bio-engineered sirolimus-eluting stent versus the Nano polymer-free sirolimus- eluting stents in the treatment of patients with de novo stenotic lesions of native coronary artery.
详细描述
This is a prospective, multi-center, open-label, non-inferiority, randomized controlled trial which plans to enroll 436 subjects. All subjects enrolled will be randomly assigned to the test group (n=218) and the control group (n=218). Subjects in the test group and the control group will receive Combo stents and Nano stents respectively.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinical evidence of asymptomatic or symptomatic ischemic heart disease, stable or unstable angina, old myocardial infarction;
- •De novo lesions of native coronary arteries (lesions number ≤2);
- •Target lesion located in one or two different vessels. The number of target lesions in one vessel shall be no more than one;
- •Target vessel diameter between 2.5 and 4.0 mm by visual estimation. Target lesion length ≤ 32mm by visual estimation, which can be covered by one Combo stent with length 38mm or one Nano stent with length 36mm. It is suggested that the selected stent size should cover at least 2 mm (by visual estimation) of normal tissue on each side of the lesion;
- •Target lesion diameter stenosis ≥ 70% by visual estimation;
- •Each target lesion is permitted to implant only one stent at most, except bailout stent;
- •Patients is eligible for PCI and is an acceptable candidate for CABG;
- •Patients with left ventricular ejection fraction (LVEF) ≥40%;
- •Patients who can understand the nature of the study, agree to participate and accept angiographic and clinical follow-up, and have provided written informed consent;
排除标准
- •Patients with acute myocardial infarction (AMI) within one week;
- •Chronic total occlusion lesion (TIMI 0 flow), Left main disease, Ostial lesion, and/or triple-vessel lesion that might require treatment, bifurcation lesions with a side branch diameter >2.5mm or graft lesions;
- •Heavily calcified or tortuous lesions which cannot be successfully pre-dilated, and lesions which are not suitable for stent delivery and deployment;
- •In-stent restenosis;
- •Thrombotic lesion;
- •Patients who had received any other stent in the past six months;
- •Patients with acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl);
- •Patients with cardiogenic shock, acute infection, known bleeding or coagulation disorder, or with a history of active gastrointestinal bleeding, ulcer, cerebral hemorrhage or subarachnoid hemorrhage and stroke within 6 months;
- •Patients who are allergic to aspirin, clopidogrel, ticagrelor, ticlopidine, heparin, contrast agent, sirolimus, stainless steel , polymer, or with contraindication to aspirin or clopidogrel or ticagrelor;
- •Patients who had previously received murine therapeutic antibodies and exhibited sensitization through the production of HAMA;
- •Patients with a life expectancy less than 1year;
- •Patients who had participated in another investigational drug or device trial that has not completed the primary endpoint;
- •Patient who has received any organ transplant or is on a waiting list for any organ transplant;
- •Patient is in the opinion of the investigator, unable to comply with the requirements of the study protocol
结局指标
主要结局
In-segment late lumen loss (LLL)
时间窗: 9 months post-procedure
In-segment late lumen loss (LLL) refers to within the margins of the stent and 5 mm proximal and 5 mm distal to the stent.
次要结局
- In-stent late lumen loss (LLL)(9 months post-procedure)
- In-stent and In-segment minimal lumen diameter (MLD)(9 months post-procedure)
- Device-oriented target lesion failure (TLF)(30 days, 6 months, 12 months and annually up to 5 years)
- Patient-oriented composite endpoint(30 days, 6 months, 12 months and annually up to 5 years)
- In-stent and In-segment binary restenosis (BR)(9 months post-procedure)
- Definite and probable stent thrombosis (ST)(acute (0-24 hours), sub-acute (24 Hours to 30 Days), late (30 Days to 1 year) and very late (1 year to 5 years) period per Academic Research Consortium (ARC) definition criteria)
研究者
研究点 (15)
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