Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Rate of Device related Serious Adverse Event at Index procedure
研究概览
简要总结
The purpose of Case-Specific Health Care Professional (HCP) Clinical Survey of Liberant™ Thrombectomy System, also known as the Liberant Clinical Assessment, is to collect first-in-human clinical data to confirm the safety and performance of the Medtronic Liberant™ thrombectomy system when used for the removal of fresh, soft emboli or thrombi from the vessels of the peripheral arterial and venous systems
详细描述
The Liberant Clinical Assessment is a multicenter, prospective per patient HCP recollection survey. Participating HCPs will document their individual case experience following routine utilization of Liberant in accordance with the approved device labeling. Individual use cases will be entered within 72 hours of device usage to identify periprocedural incidents of risk and evaluate device performance. At least 50 use cases will be collected and aggregated from at least 10 participating HCPs. This data collection is for a single point in time, with no patient follow-up. Individual HCP responses for each case will be aggregated by a third party vendor.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient case selection to be included in the clinical assessment will be specific to Liberant and will be made according to the following criteria:
- •Patient treated is age ≥ 22 years at the time of procedure
- •Use of Liberant in accordance with the device labeling within 72 hours of index procedure
排除标准
- 未提供
结局指标
主要结局
Rate of Device related Serious Adverse Event at Index procedure
时间窗: Index Procedure
An Adverse Event that converted to Serious Adverse Event, involving the function of the subject device, or the presence of the device in the body, including events that are directly attributable to the Liberant Thrombectomy System
Rate of technical success at Index procedure
时间窗: Index procedure
Technical success: Successful introduction, delivery, aspiration of fresh, soft emboli or thrombi, and retrieval of the Liberant per the Instructions for Use (IFU) during the index procedure
Rate of Procedural Success at Index procedure
时间窗: Index procedure
Procedure success: Successful removal of fresh, soft emboli or thrombi and restoration of adequate blood flow, inclusive of all endovascular therapies during the index procedure
次要结局
未报告次要终点