Inperia Advance Carbostent™ for Infra-popliteal Artery Stenosis. Evaluation of Safety and Performance in Everyday Clinical Practice: The Inperia Advance 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
- Rate of Major Adverse Events (MAE)
研究概览
简要总结
The Inperia Advance Carbostent™ is a CE-marked infra-popliteal stent for treatment of infra-popliteal artery stenosis. The aim of this post-market retrospective study protocl P32203 is to collect clinical data of patients treated with Inperia Advance for the treatment of infra-popliteal artery stenosis 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 device at least 12 months prior to the study start.
详细描述
The objective of this post-market study is to systematically collect retrospective clinical data on the implantable medical device Inperia Advance in the daily clinical practice in an unselected population treated within the intended use. Data will be collected via medical chart review in anonymous form to assess the safety and efficacy of Inperia Adavance. The Inperia Advance Carbostent™ is a CE-marked infra-popliteal stent for treatment of infra-popliteal artery stenosis.
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
- •Patient has been implanted with at least one Inperia Advance device according to the indications described in the Instructions for Use (IFU).
- •Study device implantation date is at least one year (12 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
Rate of Major Adverse Events (MAE)
时间窗: 12 months
Composite endpoint of all causes of death, unplanned target limb major amputation and/or clinically indicated target lesion revascularization (TLR)
次要结局
- Death(30 days)
- Primary patency(6 months and 12 months)
- Secondary patency(6 months and 12 months or latest patency data available)
- Target limb ischemia(6 months and 12 months)
- Acute success (device and procedural) within discharge(24/72 hours)
- Limb-salvage rate (LSR)(6 months and 12 months)
- Clinically driven Target Lesion Revascularization(6 months and 12 months)
- Rutherford category measurement(pretreatment, 6 months and 12 months)
- Evaluation of Serious Adverse Events (SAEs)(6 months and 12 months)