REal World Advanced Experience of BioResorbable ScaffolD by SMart Angioplasty Research Team (SMART REWARD)
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- cardiac death
研究概览
简要总结
Current drug-eluting stents (DES) has demonstrated excellent clinical outcomes in patients with coronary artery disease. However, a continued risk of clinical events even several years after the procedure is reported. Stent platform or polymer-associated inflammation may play a role.
Bioresorbable scaffold (BRS) is known to disappear 2 to 3 years after the implantation, which may result in the more favorable very long-term clinical outcomes compared with metallic stents. The initial clinical experiences of BRS in relatively simple lesion subsets were comparable to DESs.
BRS, however, is limited by the disadvantageous mechanical characteristics such as thick strut and the risk of fracture by overdilation. There is concern that BRS is less optimal for complex lesion subsets such as bifurcation lesions, calcified tortuous lesions, or diffuse long lesions. Real world registry is needed to test the feasibility and safety of BRS in these complex lesion subsets.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be between 19 and 70 years old.
- •Patients with a significant lesion in a de novo coronary artery: a percent diameter stenosis (DS) 50% with 1) a positive history of recurrent angina pectoris; (2) objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent); or (3) abnormal results of any invasive functional diagnostic test (eg, fractional flow reserve) or a percent DS ≥70% even in the absence of the above-mentioned ischemic signs or symptoms.
- •Patients are scheduled for coronary intervention
- •He/she or his/her legally authorized representative provides written informed consent
排除标准
- •Experience of cardiopulmonary resuscitation
- •Cardiogenic shock
- •Expected survival less than 2 years
- •Pregnancy or breast feeding
- •Opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
结局指标
主要结局
cardiac death
时间窗: 2 years
Target vessel failure (TVF) of cardiac death, myocardial infarction (MI) attributed to the target vessel, and target vessel revascularization (TVR)
次要结局
- Device success(maximum of 7 days)
- Procedural success(maximum of 7 days)
- Target vessel failure (TVF)(1, 3, and 5 years)
- Each component of Target vessel failure (TVF)(1, 2, 3 and 5 years)
- Periprocedural enzyme elevation(1, 2, 3 and 5 years)
- Definite or probable stent thrombosis(1, 2, 3 and 5 years)
- Target lesion failure(1, 2, 3 and 5 years)
研究者
Hyeon-Cheol Gwon
MD,PhD
Samsung Medical Center