Post Market Clinical Follow-up Study - PMCF Study, Serranator® Alto
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Performance
研究概览
简要总结
The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® Alto in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario.
详细描述
Single Arm, multi-center, device registry study capturing de-identified data on a minimum of 100 subjects with peripheral artery disease (PAD) and/or dysfunctional native or synthetic arteriovenous dialysis fistulae. The study will capture acute angiographic data.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 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
Performance
时间窗: The registry will collect acute procedural data through hospital discharge, no additional follow up is required. Performance data will be summarized after enrollment is complete, estimated to be 1 year.
Device Success defined as the achievement of successful delivery, balloon inflation and deflation, and retrieval of the study device(s) with a diameter stenosis of \<50% by visual assessment at the intended target site after using the Serranator® device.
次要结局
- Collection of device related Major Adverse Events (MAE) until discharge(Within 12-24 hours post-procedure or prior to hospital discharge, whichever occurs first)