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

Aortic Aneurysm, Abdominal Clinical Trial

— PRICELESS  

Official title:

PRessure and Imaging—Using the CardioMEMS EndoSure Sensor for Long-term Follow-up After EVAR With Standard Surveillance (Prospective Registry)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00831870
• Other study ID #: CM-06-02b
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 28, 2009
• Last updated: August 29, 2012
• Start date: October 2008
• Est. completion date: October 2012

Study information

• Verified date: August 2012
• Source: CardioMEMS
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 900
• Est. completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CardioMEMS