REal World Advanced Experience of BioResorbable ScaffolD by SMart Angioplasty Research Team (SMART REWARD)
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.
研究概览
研究类型
注册 (预期的)
联系人和位置
学习地点
-
-
-
Seoul、大韩民国、135-710
- 招聘中
- Cardiac and Vascular Center; Samsung Medical Center
-
接触：
- Hyeon-Cheol Gwon, Professor
- 电话号码：82234103419
- 邮箱：hc.gwon@samsung.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 观测模型：其他
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Bioresorbable Scaffold
Patients receiving percutaneous coronary intervention (PCI) for coronary artery disease using Absorb™(Abbott Vascular)
|
The implantation procedure of an Absorb™ is similar to a metallic stent.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
cardiac death
大体时间：2 years
|
Target vessel failure (TVF) of cardiac death, myocardial infarction (MI) attributed to the target vessel, and target vessel revascularization (TVR)
|
2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Device success
大体时间：maximum of 7 days
|
Successful delivery and deployment of the study scaffold at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable).
|
maximum of 7 days
|
|
Procedural success
大体时间：maximum of 7 days
|
Achievement of final in-scaffold residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat target lesion revascularization (TLR) during the hospital stay (maximum of 7 days).
|
maximum of 7 days
|
|
Target vessel failure (TVF)
大体时间：1, 3, and 5 years
|
cardiac death, target vessel MI, or TVR
|
1, 3, and 5 years
|
|
Each component of Target vessel failure (TVF)
大体时间：1, 2, 3 and 5 years
|
Cardiac death,Vascular death,Non-cardiovascular death,Myocardial Infarction (MI)
|
1, 2, 3 and 5 years
|
|
Target lesion failure
大体时间：1, 2, 3 and 5 years
|
Target lesion failure of cardiac death, MI attributed to the target vessel, and Target Lesion Revascularization(TLR). TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel.
The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself.
|
1, 2, 3 and 5 years
|
|
Definite or probable stent thrombosis
大体时间：1, 2, 3 and 5 years
|
1, 2, 3 and 5 years
|
|
|
Periprocedural enzyme elevation
大体时间：1, 2, 3 and 5 years
|
1, 2, 3 and 5 years
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.