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

NCT00831870 | Unknown

• 1 other identifier: CM-06-02b
• Study Type: observational
• Target: 900
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aortic Aneurysm, Abdominal

Keywords

EndoSure Sensor; s2 Sensor; abdominal aortic aneurysm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Subjects whose clinical condition, in the Investigator's opinion, would not allow them to complete participation in the registry.

Sponsors & Collaborators

• CardioMEMS: lead

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2009
• First Posted: January 29, 2009
• Study Start: October 1, 2008
• Study Completion: October 1, 2012
• Last Updated: August 30, 2012

Record last verified: 2012-08