Study Title

CardioMEMS, Inc: Feasibility Evaluation of the CardioMems Abdominal Aortic Aneurysm Pressure Sensor System. APEX Study (Acute Pressure Measurement to Confirm Aneurysm Sac Exclusion).

Study Dates: 2004 – August 2010 (study to be renewed)

Lead Investigator: Elliot L. Chaikof, MD, PhD

This investigation will assess a new sensor system that can directly measure aneurysm sac pressure following endograft placement. An aneurysm can be repaired with stent grafts that form a new channel for blood flow that then isolates the aneurysm from pressure, though blood can leak into the aneurysm sac post procedure (endoleak). Pressure from such leaks stretches the wall of the aneurysm and can cause the sac to rupture. Presently, only indirect methods are available for measurement of sac pressure after graft placement, such as CT scan, ultrasound, or angiogram, and there are no devices currently on the market that directly measure sac pressure.

The sensor system being evaluated requires no batteries, relies on a separate antenna as a power source, and can directly measure pressure in the aneurysm sac in a manner that existing technology such as CT scanning is incapable of, potentially giving physicians detailed data they’ve never been able to obtain before.

Prior to stent graft placement, the sensor will be placed in the patient’s aneurysm sac. After the stent graft has been implanted, pressure readings will be obtained by holding an antenna against the patient’s back, abdomen or side in the area of the sensor. Radio frequencies from the antenna obtain readings from the sensor that will be displayed on a laptop computer. Pressure readings will be taken in the operating room immediately following the procedure, throughout the first postoperative day, and during the standard post AAA repair follow-up examinations for a five year period.

• Must be older than 18 years of age.
• Cannot be pregnant.
• Cannot present with an AAA rupture.
• Cannot weigh more than 350 lbs.
• Cannot be participating in another endovascular AAA stent graft study.
• Must need a bifurcated, modular endovascular stent graft for the treatment of an infrarenal abdominal aortic or aorto-iliac aneurysm.
• Must have more than one-year life expectancy post-procedure.

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