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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00831870
Recruitment Status : Unknown
Verified August 2012 by CardioMEMS.
Recruitment status was:  Enrolling by invitation
First Posted : January 29, 2009
Last Update Posted : August 30, 2012
Information provided by (Responsible Party):

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.

Condition or disease
Aortic Aneurysm, Abdominal

Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PRessure and Imaging—Using the CardioMEMS EndoSure Sensor for Long-term Follow-up After EVAR With Standard Surveillance (Prospective Registry)
Study Start Date : October 2008
Estimated Study Completion Date : October 2012

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male or female subjects, at least 18 years of age, who are post-EndoSure AAA Pressure Sensor implantation at time of enrollment.

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.

Responsible Party: CardioMEMS Identifier: NCT00831870     History of Changes
Other Study ID Numbers: CM-06-02b
First Posted: January 29, 2009    Key Record Dates
Last Update Posted: August 30, 2012
Last Verified: August 2012

Keywords provided by CardioMEMS:
EndoSure Sensor
s2 Sensor
abdominal aortic aneurysm

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases