Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Rate of peri-procedural adverse events
研究概览
简要总结
The purpose of the Case-Specific Health Care Professional (HCP) Clinical Survey for Concerto Versa™ Detachable Coils, also known as the Concerto Versa HCP Clinical Assessment, is to collect early clinical data from HCPs to assess clinical safety and performance of the Concerto Versa™ Detachable Coils, when used in accordance with approved device labeling per the Instructions for Use (IFU). Data collected will generate clinical evidence to quantitatively assess clinical safety and device performance for the purpose of obtaining European Union Medical Device Regulation (EU MDR) approval.
详细描述
The Concerto Versa™ Health Care Professional (HCP) Clinical Assessment is a multicenter, prospective per patient HCP recollection survey. Participating HCPs will document their individual use case experience following routine utilization of Concerto Versa™ in accordance with the approved device labeling. Individual use cases will be entered within 72 hours of device usage to identify periprocedural safety incidents and evaluate device performance. At least 30 use cases will be collected and aggregated from participating HCPs. This data collection is a 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 treated with Concerto Versa™ Detachable Coil is age ≥ 22 years at the time of procedure.
- •Use of Concerto Versa™ Detachable Coil in accordance with the device labeling.
- •Reporting of case within 72 hours of index procedure.
排除标准
- 未提供
研究组 & 干预措施
Adult patients treated with Concerto Versa™ Detachable Coil
The Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in adult patients requiring embolization in the peripheral vasculature.
干预措施: Concerto Versa™ Detachable Coils (Device)
结局指标
主要结局
Rate of peri-procedural adverse events
时间窗: During the Index Procedure
The rate of peri-procedural adverse events related to device and/or procedure.
Rate of Technical Success
时间窗: During the Index Procedure
Technical success is defined as successful delivery and detachment of the coil, and removal of the delivery-pusher.
次要结局
- Rate of Peri-procedural success(During the Index Procedure)