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Multi-institutional Pivotal Trial of the Zenith TX2 Thoracic Aortic Stent-Graft for Treatment of Descending Thoracic Aortic Aneurysms: Clinical Study Design

Department of Surgery, Division of Vascular Surgery, Northwestern University Feinberg School of Medicine

Michael D. Dake, MD

Department of Radiology, University of Virginia;

Lars G. Svensson, MD PhD

Thoracic and Cardiovascular Surgery

Roy K. Greenberg, MD

Vascular Surgery, The Cleveland Clinic Foundation

Richard P. Cambria, MD

Department of Surgery, Division of Vascular Surgery, Harvard Medical School

Randy D. Moore, MD

Depaitment of Surgery, Division of Vascular Surgeiy, University of Calgary

Jon S. Matsumura, MD

Northwestern University Feinberg School of Medicine, Division of Vascular Surgery, Suite 10-105, 201 East Huron Street, Chicago, IL 60611

Despite significant improvements in surgical techniques and perioperative management, the repair of descending thoracic aortic aneurysms remains a challenge with the potential for substantial morbidity and mortality. Over the past several years, buoyed by the technical success of endovascular repair of infrarenal abdominal aortic aneurysms, several case series reports of endovascular stent-graft placement for descending thoracic aortic aneurysms have demonstrated the potential safety and efficacy of this treatment modality. Several single-institution studies have documented promising results with these devices, but without controlled clinical trials, the data are insufficient to determine if thoracic aortic endografts provide equivalent or improved outcomes compared with standard open repair. We describe a study design of an ongoing prospective, nonrandomized, multi-institutional, investigational device exemption phase 11 pivotal clinical trial investigating the safety and effectiveness of the Zenith TX2 thoracic aortic endovascular graft in the elective treatment of patients with descending thoracic aortic aneurysms.

Key Words: descending thoracic aortic aneurysms • endovascular stent graft • thoracic aortic endografts

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