Cook Initiates Enrollment in STABLE Trial on Aortic Dissection


March 25, 2008

March 25, 2008 - Researchers have just completed the first European case in a global clinical trial, the STABLE trial, designed to evaluate the Cook Zenith Dissection Endovascular System, a device designed specifically to treat aortic dissections.

Christoph A. Nienaber M.D., Ph.D., site investigator at the University of Rostock in Germany, who serves as head of cardiology at the University of Rostock, was assisted during the procedure by colleagues Huseyin Ince, M.D., Ph.D.; Thomas Korber, M.D.; and Stephan Kische, M.D. The global principal investigator for the trial is Joseph Lombardi, M.D., assistant professor at Thomas Jefferson University Hospital in Philadelphia, PA.

“This is the first real dissection-specific endovascular approach to this condition,” Dr. Nienaber said of his experience with the Cook Zenith Dissection Endovascular System. “It stabilizes the entire dissection with a petticoat (stent graft and bare stent) without compromising important abdominal side branches.”

The first European patient found suitable for inclusion in the STABLE dissection clinical trial was a 71-year-old male diagnosed with a Type B dissection of his thoracic aorta. The patient was treated with the Cook Zenith Dissection Endovascular System, which is comprised of the new Cook Zenith Dissection Stent, used in conjunction with the Cook Zenith TX2 Endovascular Graft. A Zenith TX2 Proximal Tapered Component stent graft sealed the entry tear in the thoracic aortic arch, and a bare Zenith Dissection Endovascular Stent was placed in the region where the aorta’s true lumen had collapsed.

The Cook Zenith Dissection Endovascular System is used in the endovascular treatment of descending thoracic aortic dissection in patients with anatomies appropriate for endovascular repair. The device has unique Z-stents that exert pressure allowing gradual apposition of the dissection septum and re-expansion of the true lumen, while keeping important arteries exposed that supply the spinal cord with blood.

Clinicians hope endovascular aortic repair (EVAR) will offer a solution that will eliminate the need for highly invasive, traumatic open surgery for thoracic aneurysms and dissections. Rather than opening the chest cavity and clamping off the aorta to surgically implant a graft to treat the damaged section of the thoracic aorta, physicians insert a catheter loaded with a self-expanding, fabric covered stent-graft through a surgical opening in the femoral artery.

The catheter is guided through the patient’s blood vessels under fluoroscopy until the device is positioned across the dissected section of the aorta. The stent-graft then expands upon deployment from the catheter to reopen the original path through the aorta and should reduce blood flow into the false pathway in the damaged vessel wall, thereby restoring normal aortic blood flow. The uncovered Zenith Dissection Stent is used to expand the true lumen in the distal thoracic aorta where preservation of the side branch artery blood flow is critical.

The Cook Zenith Dissection Endovascular System is an investigational device not available in the European Union or U.S.

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