NCT03330002已完成不适用
Post-Market Clinical Registry to Evaluate the Safety and Performance of MANTA Vascular Closure Device (VCD) Under Real World Conditions in the European Union (EU)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 9
- 主要终点
- Number of Participants With One or More Major Access Site Related Complications
研究概览
简要总结
The aim of this observational post market study is to compile real world outcome data on the use of the Conformité Européenne (CE) marked MANTA Vascular Closure Device following percutaneous cardiac or peripheral procedures for large bore (10-18F ID) interventional devices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants With One or More Major Access Site Related Complications
时间窗: within 30 days of procedure
Major access site related complications adapted from the VARC-2 definitions
Time to Hemostasis
时间窗: Immediately after deployment of MANTA VCD
The elapsed time between MANTA deployment (withdrawal of sheath from artery) and first observed and confirmed arterial hemostasis (no or minimal subcutaneous oozing and the absence of expanding or developing hematoma).
次要结局
- Number of Participants With One or More Minor Access Site Related Complications(within 30 days of procedure)
研究者
研究点 (9)
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