Clinical Study on Absorb Polylactic, Reabsorbable Coronary Scaffold (RAI)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,520
- 试验地点
- 1
- 主要终点
- Scaffold thrombosis
研究概览
简要总结
The investigators aim at evaluating the long-term (5-year) clinical outcome following Absorb BVS implantation in a real world, all-comers population of consecutive patients, as treated according to the indications, techniques and protocols used in the participating institutions.
详细描述
Long-term data after implantation of coronary BVS is scarce, especially in subgroups of patients with diabetes or chronic kidney disease, and in those with complex coronary lesions and/or multivessel disease.
Although the use of BVS is very promising in younger patients with one or more of the above characteristics, evidence of benefit is not available.
The BVS-RAI Registry is a spontaneous initiative of a group of Italian interventional cardiologists who are interested in assessing the results of their interventional practice with BVS, by sharing data.
The BVS-RAI Registry has been created in joint-venture with Centro di Ricerche Farmacologiche e Biomediche "Mario Negri Sud", and is not recipient of funding or benefits originating from the BVS manufacturer or seller. BVS devices are regularly purchased by the participating centres.
Each participating centre is willing to input data of all consecutive patients treated with BVS, with a minimum of 50, and to report on follow-up for at least 5 years. Patient recruitment is not directed per protocol, nor is it rewarded. Patients who give informed consent are included in the BVS-RAI Registry after BVS implant has been performed following the indications, techniques and protocols used in each of the participating institutions.
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
- — 至 75 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Successful implantation of 1 or more coronary BVS
- •Age <75 years
- •Patient's informed consent
排除标准
- 未提供
结局指标
主要结局
Scaffold thrombosis
时间窗: 1 year
acute, subacute, late and very late
Target lesion revascularization
时间窗: 1 year
ischemia or angiographic-driven
次要结局
- MACE(5 year)
研究者
Dr Giuseppe Steffenino
MD
Ospedale Santa Croce-Carle Cuneo
