January 24, 2005

SIU Med School Is Recruiting Patients for National TAA Trial

Patients are being recruited by the Southern Illinois University School of Medicine as part of a 40-site national clinical trial for the treatment of thoracic aortic aneurysms (TAAs). SIU's Division of Vascular Surgery is evaluating the efficacy and safety of a minimally invasive treatment option utilizing stent grafts for treatment of patients with these life-threatening aneurysms of the aorta, the body’s largest artery.

"Historically, we have had very few treatment options for patients with TAAs. The VALOR system, if proven to be safe and effective in this trial, could well provide a new and less invasive option over other treatments," said Dr. Kim Hodgson, professor and chair of vascular surgery at SIU, who is directing the study. "We hope to be able to build on the wealth of experience we gained when we were involved with clinical trials for stenting of the abdominal aortic aneurysms."

The study of the VALOR system, which uses a Talent Thoracic Stent Graft, is a prospective, non-randomized trial and is currently enrolling patients diagnosed with TAAs who are considered candidates for open surgical repair and are of low to moderate risk of major complications. To be eligible, patients must be between 18 and 85 years of age. Patients will be evaluated over a planned treatment period of approximately one year with a minimum of four visits and required life-long annual follow-up. Each participant will receive a physical examination and other tests before beginning. The study is sponsored by Medtronic Vascular, Inc. Results will be shared with the participant's personal physician.

The thoracic aorta, located in the upper chest and surrounded by the ribs, is vulnerable to the development of aneurysms. Chest or back pain may indicate an aneurysm, but most people have no symptoms until they rupture.

For study participants, the stent graft is introduced through a small opening in the femoral artery of the leg and advanced under fluoroscopic guidance to the site of the thoracic aortic aneurysms, where it is then deployed. Once placed, the stent graft expands to fit within the diameter of the aorta, thereby excluding the aneurysm by providing a new path for blood.

It is estimated more than 30,000 patients are diagnosed with TAAs yearly in the U.S. A number of these patients also have other serious conditions such as coronary artery disease, emphysema, high blood pressure and diabetes that increase the risk of survival with repair performed through open surgery, which is the current standard of care. For those patients considered ineligible for open surgical repair, there have been few treatment options.

If you are interested in participating in the study, call Carol at 217-545-2320 or Tiffany at 217-545-2531, both in SIU's Vascular Surgery Division, weekdays for an initial screening.

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