June 2005

 Emory Participates in Trial of New Procedure to Treat TAA

A clinical trial is underway at Emory University to study the safety and effectiveness of an endovascular medical device used to treat life-threatening thoracic aortic aneurysms (TAA). Vascular surgeon Ross Milner, MD, is one of 35 principal investigators in North America to participate in the trial, called STARZ-TX2 (Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2(TM) Thoracic TAA Endovascular Graft), and is the lead investigator for the Emory site. The trial will compare the outcomes of open surgery to treatment with the Zenith TX2 Thoracic TAA Endovascular Graft, manufactured by Cook Incorporated, in approximately 275 patients diagnosed with a descending thoracic aortic aneurysm. The Zenith TX2 Thoracic TAA Endovascular Graft is an investigational device, limited by federal (U.S.) law to investigational use. Specifically, the trial will assess device performance, as well as patient survival and aneurysm rupture rates between the surgical and endovascular treatment groups, over a 12-month period.

"Aneurysms in the descending thoracic aorta are a time-sensitive condition that increases patient risks for life-threatening rupture," says Dr. Milner. "The non-surgical approach used in the STARZ-TX2 trial could benefit thousands of lives because it's a less invasive and lower risk procedure compared to the open-chest operation."

Currently, surgical repair is the standard for treating TAAs, requiring a surgeon to open the chest cavity, clamp off the aorta and sew a surgical graft in place to prevent an aneurysm from rupturing. The method carries high health risks for many older patients, who may also suffer from such conditions as heart and/or lung disease, diabetes, or hypertension.

The Zenith TX2 system requires an incision to insert the graft's hydrophilic, kink-resistant delivery system into the femoral artery in the leg. When the system is guided into position through the patient's arteries under fluoroscopy, a one- or two-piece, fabric-covered, self-expanding stent graft is placed inside the weakened section of the thoracic aorta to relieve pressure on the aneurysm, helping to reduce the risk of rupture.

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