RADIX 2 RENAL ARTERY STENT Evaluation of Safety and Performance in Everyday Clinical Practice: Post-Market Retrospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Major renal events
研究概览
简要总结
The Carbostent™ Radix 2 stent is a CE marked balloon expandable bare metal stent for the treatment of renal artery stenosis.
The aim of this post-market retrospective study protocol P12204, is to collect clinical data on patients treated with the RADIX 2 stent in routine clinical practice.
In order to obtain long-term follow-up data, the data collection will be limited to patients that have been treated with the Radix 2 stent at least 12 months prior to the study start.
详细描述
The objective of this post-market study is collect retrospective clinical data on the implantable medical device Radix 2 stent in an unselected population treated in the current clinical practice. Data will be collected via medical chart review in anonymous form.
Radix2 is a bare metal balloon expandable stent with a progressive multicellular design for treatment of renal artery stenosis. The stent is stent coated with i-Carbofilm™ to accelerate the rate of endothelization and strut coverage.
The product is CE marked and commercially available since July 2010. Additional technical information on RADIX2 is available online: http://www.alvimedica.com/Product/15/bms-b-e-radix2
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study will be conducted in the "real world" population, according to the following criteria.
- •Selection criteria:
- •Patient has been implanted with at least one study stent (Radix2) according to the indications described in the IFU.
- •Study Device Implanted is at least12 months prior to the starting date of the retrospective anonymous data collection.
排除标准
- •Patients treated less than 12 months prior to study start
结局指标
主要结局
Major renal events
时间窗: 30 days
Major renal events at 30 days - composite of: death from renal causes, related to study device or procedure; embolic events related to study device or procedure, resulting in kidney damage; acute kidney injury Stage 3 (AKIN criteria); ipsilateral nephrectomy, related to the study device or procedure.
次要结局
- Technical success(24 hours)
- In Stent Restenosis(12 months)
- Arterial Blood Pressure(12 months)
- Acute device success(24 hours)