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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

January 28, 2009
August 29, 2012
October 2008
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Complete list of historical versions of study NCT00831870 on ClinicalTrials.gov Archive Site
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EndoSure Sensor for Long-term Follow-up After Endovascular AAA Repair
PRessure and Imaging—Using the CardioMEMS EndoSure Sensor for Long-term Follow-up After EVAR With Standard Surveillance (Prospective Registry)

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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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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.

Aortic Aneurysm, Abdominal
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
900
October 2012
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00831870
CM-06-02b
No
CardioMEMS
CardioMEMS
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CardioMEMS
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP