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

NCT ID: NCT00831870

Last Updated: 2012-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 900 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2012-10-31

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.

Conditions

Aortic Aneurysm, Abdominal

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardioMEMS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CM-06-02b

Identifier Type: -

Identifier Source: org_study_id