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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Aneurysm, Abdominal

Keywords

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EndoSure Sensor s2 Sensor abdominal aortic aneurysm

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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CM-06-02b

Identifier Type: -

Identifier Source: org_study_id