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Sponsored by: |
CardioMEMS |
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Information provided by: | CardioMEMS |
ClinicalTrials.gov Identifier: | NCT00831870 |
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.
Condition |
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Aortic Aneurysm, Abdominal |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | PRessure and Imaging—Using the CardioMEMS EndoSure Sensor for Long-Term Follow-up After EVAR With Standard Surveillance (Prospective Registry) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Male or female subjects, at least 18 years of age, who are post-EndoSure AAA Pressure Sensor implantation at time of enrollment.
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | CardioMEMS, Inc. ( Ben Gofredo, Clinical Project Manager ) |
Study ID Numbers: | CM-06-02b |
Study First Received: | January 28, 2009 |
Last Updated: | January 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00831870 History of Changes |
Health Authority: | United States: Institutional Review Board |
EndoSure Sensor s2 Sensor abdominal aortic aneurysm |
Aortic Diseases Aneurysm Aortic Aneurysm, Abdominal |
Vascular Diseases Aortic Aneurysm Abdominal Aortic Aneurysm |
Aortic Diseases Aneurysm Aortic Aneurysm, Abdominal |
Vascular Diseases Cardiovascular Diseases Aortic Aneurysm |