Hassoun Heitham T, Matsumura Jon S
Department of Surgery, Division of Vascular and Endovascular Surgery, Johns Hopkins Hospital, Baltimore, MD, USA.
Semin Vasc Surg. 2006 Mar;19(1):32-9. doi: 10.1053/j.semvascsurg.2005.11.003.
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.
胸主动脉病变的血管内治疗（ETAP）已发展了十多年。直到最近，美国才批准了一种用于治疗降主动脉瘤的装置。这一研发过程漫长是因为对多个装置和输送系统进行了改进，同时人们对胸主动脉重建的独特挑战的认识也在不断发展。TX2系统已从开创性的定制设计发展成为一个成熟的系统，具有多项旨在改善早期和晚期治疗效果的特性。有必要进行对照试验，以比较ETAP与标准开放修复的治疗结果。本文将详细介绍该装置的当前一代产品，回顾已发表的大型单中心经验，并描述一项正在进行的前瞻性、非随机、多机构、研究性器械豁免（IDE）II期关键临床试验，该试验旨在研究该装置在选择性治疗降主动脉瘤患者中的安全性和有效性。
