NCT00831870Unknown不适用
PRessure and Imaging-Using the CardioMEMS EndoSure Sensor for Long-term Follow-up After EVAR With Standard Surveillance (Prospective Registry)
适应症
试验速览
- 阶段
- 不适用
- 发起方
- CardioMEMS
- 入组人数
- 900
研究概览
简要总结
The purpose of this study is to collect and compare EndoSure and EndoSure s2 Wireless AAA Pressure Sensor measurements with measurements from CT scan imaging, ultrasound, and other tests used to measure your AAA sac size and endoleaks following AAA repair, and during follow-up visits with your physician. An antenna is held over the patient's abdomen to measure pressure inside the aneurysm sac. The reading does not cause any discomfort, and dye or radiation is not needed to take the pressure measurement. To qualify, the patient must have a previously implanted EndoSure Sensor.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Written informed consent obtained from subject or legal guardian
- •Males or females, at least 18 years of age
- •Subjects who are post-EndoSure Wireless AAA Pressure Sensor implantation, with pressure measurements at implant.
- •Subjects willing to comply with the site-specific follow-up requirements of the investigator.
排除标准
- •Subjects whose clinical condition, in the Investigator's opinion, would not allow them to complete participation in the registry.
研究者
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