EndoSure Sensor for Long-term Follow-up After Endovascular AAA Repair

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00831870

Acronym

PRICELESS

Enrollment

900

Registered

2009-01-29

Start date

2008-10-31

Completion date

2012-10-31

Last updated

2012-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Aneurysm, Abdominal

Keywords

EndoSure Sensor, s2 Sensor, abdominal aortic aneurysm

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* Subjects whose clinical condition, in the Investigator's opinion, would not allow them to complete participation in the registry.

Outcome results