Observational Study of Treatment of Bioresorbable Vascular Scaffolds Restenosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Combined clinical end-point (cardiac death, myocardial infarction and target vessel revascularization)
研究概览
简要总结
The treatment of patients with intra-stent restenosis (ISR) of Bioresorbable Vascular Scaffolds (Abbott Vascular) remains a challenge. This study will assess the incidence, predisposing factors, pathophysiology and prognosis of the patient in this setting.
详细描述
Treatment of patients with ISR remains a challenge. Currently both drug-eluting stents (DES) and drug-coated balloons (DCB) are considered as the strategies of choice in this setting. However, existing data about ISR of BVS are scarce (isolated cases and retrospective series with very few patients) on the incidence, predisposing factors, pathophysiology, treatment, and long-term prognosis of these patients. In this sense, a prospective Spanish registry of patients with ISR of DVB can obtain a very relevant clinical information that allows us to advance in our knowledge about this phenomenon that helps to prevent it and to treat it in the safest and most effective way possible.
Clinical events will be adjudicated by an independent Clinical Event Committee.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Combined clinical end-point (cardiac death, myocardial infarction and target vessel revascularization)
时间窗: 1 year of clinical follow-yp
This is a well-accepted outcome measure of individual clinical end-points. Definition of myocardial infarction is similar to that used in previous RIBS studies. The occurrence of ANY of these events will qualify for the combined event. That is, Cardiac death OR Myocardial Infarctio OR target vessel revascularization. (for the cobined end point the first event will be censored for each patient and other subsequent events will not apply). For time related statistics, the first event will be censored in the KM curves. In addition to that, the time and occurrence of each individual event will be also analyzed. The same strategy will be followed for the other combined clinical outcome measures that, again, are classically defined in this field.
次要结局
- Stent thrombosis(1 year, 2 years, 3 years, 4 years, 5 years)
- Major bleeding(1 year, 2 years, 3 years, 4 years, 5 years)
- Combined clinical outcome measure (cardiac death, myocardial infarction, target lesion revascularization)(1 year, 2 years, 3 years, 4 years, 5 years)
- Cardiac death(1 year, 2 years, 3 years, 4 years, 5 years)
- Target-lesion failure (defined as cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization)(1 year, 2 years, 3 years, 4 years, 5 years)
- Target vessel revascularization(1 year, 2 years, 3 years, 4 years, 5 years)
- Total mortality(1 year, 2 years, 3 years, 4 years, 5 years)
- Myocardial infarction(1 year, 2 years, 3 years, 4 years, 5 years)
- Target lesion revascularization(1 year, 2 years, 3 years, 4 years, 5 years)
研究者
Fernando Alfonso
MD, Principal Investigator
Spanish Society of Cardiology