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临床试验/NCT00831870
NCT00831870Unknown不适用

PRessure and Imaging-Using the CardioMEMS EndoSure Sensor for Long-term Follow-up After EVAR With Standard Surveillance (Prospective Registry)

CardioMEMS0 个研究点目标入组 900 人开始时间: 2008年10月最近更新:
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

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

发起方
CardioMEMS
申办方类型
Industry
责任方
Sponsor

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