AVERT Plus Post-Market Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Contrast media volume usage
研究概览
简要总结
The devices used in this observational registry are the Osprey Medical Contrast Monitoring System (CMS) and the Osprey Medical AVERT Reflux Reduction System. Both products have CE Mark designations. The purpose of this registry is to evaluate the usability characteristics of the combined Osprey Medical AVERT System and the Contrast Monitoring System during normal clinical use.
详细描述
This is a prospective, single-center, non-randomized, single arm, observational registry of the AVERT System used in combination with the Contrast Monitoring System. Patients undergoing manual manifold injection coronary artery imaging for diagnostic or PCI procedures that utilize the AVERT System and the CMS will be included in this registry. Device use characteristics including, measurement of contrast media volume used, contrast media volume saved by the use of the AVERT System, evaluation of angiographic image quality, and physician feedback on device features and function will be obtained. All data will be collected on the day of the procedure and there will be no long-term follow-up.
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
- •Scheduled for a coronary diagnostic or PCI procedure using manual manifold injection with the AVERT System and CMS according to the labeled indications for these devices.
- •Patient consent to participate
排除标准
- 未提供
结局指标
主要结局
Contrast media volume usage
时间窗: Day of procedure
Compare cumulative contrast media volume usage as displayed by the CMS to volume estimation commonly performed in the catheterization laboratory
次要结局
- Physician feedback on device features(Day of procedure)
- Contrast media volume savings(Day of procedure)
- Angiographic image quality(Day of procedure)