The COOK TX2 thoracic stent graft: preliminary experience and trial design.

Endovascular treatment of thoracic aortic pathology (ETAP) has been under development for over a decade. Only recently has one device been approved in the United States for treatment of descending thoracic aortic aneurysms. The length of this development process is due to multiple device and deployment system modifications, as understanding has evolved of the unique challenges of reconstruction in the thoracic aorta. The TX2 system has evolved from pioneering custom-made designs into a mature system with several features designed to improve early and late results. Controlled trials are necessary to compare the outcomes of ETAP with standard open repair. This article will detail the current generation of the device, review large published single-center experiences, and describe an ongoing prospective, nonrandomized, multi-institutional, investigational device exemption (IDE) phase II pivotal clinical trial investigating the safety and effectiveness of this device in elective treatment of patients with descending thoracic aortic aneurysms.

[1]  M. Dake,et al.  Multi-institutional pivotal trial of the Zenith TX2 thoracic aortic stent-graft for treatment of descending thoracic aortic aneurysms: clinical study design. , 2005, Perspectives in vascular surgery and endovascular therapy.

[2]  R. Chiesa,et al.  Single center experience with a new commercially available thoracic endovascular graft. , 2005, European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery.

[3]  B. Lytle,et al.  Endovascular repair of thoracic aortic lesions with the Zenith TX1 and TX2 thoracic grafts: intermediate-term results. , 2005, Journal of vascular surgery.

[4]  David M. Williams,et al.  Endovascular treatment of thoracic aortic aneurysms: results of the phase II multicenter trial of the GORE TAG thoracic endoprosthesis. , 2005, Journal of vascular surgery.

[5]  N. Morrissey,et al.  Challenges of endovascular tube graft repair of thoracic aortic aneurysm: midterm follow-up and lessons learned. , 2003, Journal of vascular surgery.

[6]  T. de Chaumaray,et al.  Endovascular treatment of thoracic aortic aneurysms. , 2003, The Journal of cardiovascular surgery.

[7]  A. Lumsden,et al.  Endoluminal versus open treatment of descending thoracic aortic aneurysms. , 2002, Journal of vascular surgery.

[8]  D. C. Brewster,et al.  Evolving experience with thoracic aortic stent graft repair. , 2002, Journal of vascular surgery.

[9]  John A Elefteriades,et al.  Yearly rupture or dissection rates for thoracic aortic aneurysms: simple prediction based on size. , 2002, The Annals of thoracic surgery.

[10]  J. Bavaria,et al.  Thoracic aortic stent grafts. , 2001, Seminars in roentgenology.

[11]  C. Miller,et al.  Descending thoracic aortic aneurysm: surgical approach and treatment using the adjuncts cerebrospinal fluid drainage and distal aortic perfusion. , 2001, The Annals of thoracic surgery.

[12]  P. Taylor,et al.  Thoracic aortic stent grafts--early experience from two centres using commercially available devices. , 2001, European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery.

[13]  J. Lammer,et al.  Thoracic aortic aneurysms: treatment with endovascular self-expandable stent grafts. , 2000, The Annals of thoracic surgery.

[14]  R. S. Mitchell,et al.  Thoracic aortic aneurysm repair with an endovascular stent graft: the "first generation". , 1999, The Annals of thoracic surgery.

[15]  L. Melton,et al.  Improved prognosis of thoracic aortic aneurysms: a population-based study. , 1998, JAMA.

[16]  L. Moldawer,et al.  Visceral ischemia and organ dysfunction after thoracoabdominal aortic aneurysm repair. A clinical and cost analysis. , 1996, Annals of surgery.

[17]  S. Goldstein,et al.  Thoracic Aortic Aneurysms , 1996, Echocardiography.

[18]  S Bauer,et al.  Hypothermic bypass and circulatory arrest for operations on the descending thoracic and thoracoabdominal aorta. , 1995, The Annals of thoracic surgery.

[19]  J. Coselli,et al.  Variables predictive of outcome in 832 patients undergoing repairs of the descending thoracic aorta. , 1993, Chest.

[20]  J. Coselli,et al.  Ruptured aneurysm of the descending thoracic and thoracoabdominal aorta. Analysis according to size and treatment. , 1991, Annals of surgery.

[21]  L. Melton,et al.  Thoracic aortic aneurysms: a population-based study. , 1982, Surgery.

[22]  J. N. Young,et al.  Descending thoracic aortic aneurysm: a 10 year surgical experience. , 1981, American journal of surgery.

[23]  J. W. Pate,et al.  Acute aortic dissections. , 1976, The American surgeon.