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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
CardioMEMS
ClinicalTrials.gov Identifier:
NCT00831870
First received: January 28, 2009
Last updated: August 29, 2012
Last verified: August 2012
History of Changes
  Purpose

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
Aortic Aneurysm, Abdominal

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CardioMEMS:

Estimated Enrollment: 900
Study Start Date: October 2008
Estimated Study Completion Date: October 2012
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: CardioMEMS
ClinicalTrials.gov Identifier: NCT00831870     History of Changes
Other Study ID Numbers: CM-06-02b
Study First Received: January 28, 2009
Last Updated: August 29, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 18, 2012