PYTHAGORAS Clinical Trial

Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft

Purpose:

To evaluate the safety and effectiveness of the Lombard Medical endovascular Aorfix™ AAA bifurcated stent graft in the repair of abdominal aortic aneurysms.

Principal Investigator:

James Williams, MD, FACS, FCCP, FACC
Cardiac, Thoracic and Endovascular Therapies

For More Information Contact:

Tracy Rennie, MPH, RN
(309) 672-4808
tlrennie@mmci.org

Summary:

Patients with an abdominal aortic aneurysm (AAA) may be eligible to participate in this trial. The Aorfix™ is an experimental stent that is used to repair AAA's. Currently, there are two ways of treating aneurysms. "Open repair" involves a large cut in the abdomen. "Endovascular repair" involves a graft (the Aorfix™) that is held in a delivery catheter and moved through smaller vessels to the affected area. It allows smaller incisions to be made and is less invasive than open repair. Two groups of patients will be included in this trial. The first group will be treated with the Aorfix™ (endovascular group) and the second group will undergo open surgery (control group). Patients who agree to enter the trial will be assigned to one of the two groups based on their general medical condition and aneurysm type. Information about the patient's medical history, aneurysm and procedure will be collected for the study. Follow-up visits with the study doctor will occur at 1 week, 1 month, 6 months, 12 months and 24 months after the operation. Tests that will be performed include CT scans and x-rays. Blood will also be drawn for laboratory tests. The study is expected to last 36 - 39 months.