NCT07010354招募中不适用
An International, Multi-centre Observational Study to Evaluate Safety, Performance, and Clinical Benefit of the BeFlow Iliac Covered Stent System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Primary patency rate
研究概览
简要总结
This international, observational multi-centre study of the device BFI will monitor technical success of the implantation, data regarding clinical performance, clinical benefit, as well as potential unknown side effects pursuant to the Intended Purpose.
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
- •Patients with an indication for permanent intraluminal placement in iliac arteries for restoring and improving the patency impaired by arteriosclerosis or other stenoses that may be treated by stenting according to the IFU of the BFI
- •Patient is capable and willing to sign an informed consent
- •Patients ≥18 years of age at the time of consent
排除标准
- •Patients with any contraindication according to the IFU
- •Previous stenting of the target vessel
结局指标
主要结局
Primary patency rate
时间窗: 12 months
次要结局
- Rate of covered stent-related complications(1 month and 12 months)
- Rate of technical success(up to 1 month)
- Primary patency rate(up to 60 months)
- Secondary patency rate(up to 60 months)
- Primary assisted patency rate(up to 60 months)
- Change of Rutherford Classification(up to 60 months)
- Change of ABI(up to 60 months)
- Freedom from TLR(up to 60 months)
- Freedom from MACE(up to 60 months)
研究者
研究点 (7)
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