Roubin G S, King S B, Douglas J S, Lembo N J, Robinson K A
Department of Medicine, Emory University School of Medicine, Emory University Hospital, Atlanta, Georgia.
Circulation. 1990 Mar;81(3 Suppl):IV92-100.
A flexible, balloon-mounted, coil stent was developed to address the problems of acute closure and long-term restenosis, which currently limit the safety and efficacy of percutaneous transluminal coronary angioplasty. The device is made of 0.006-in. stainless steel suture material and is mounted on balloons, 2.5-4.5 mm in diameter, for use in the coronary circulation. Results of studies in canine coronary arteries have demonstrated long-term patency and stability, and studies in the atherosclerotic arteries of rabbits have suggested late results with stenting that might be superior to those obtained with balloon angioplasty alone. Initial clinical studies have focused on the use of the device as a "bridge" to surgery if closure occurs. The stent appears to have been successful in this application. A phase 2 study is now examining the stent as definitive therapy for acute closure in certain anatomic subsets of patients. Information on long-term patency is pending. If this is favorable, the device will be studied to see if it reduces the incidence of restenosis in the subset of patients in whom balloon dilatation alone fails to produce an optimal hemodynamic result.
为解决急性血管闭塞和长期再狭窄问题，研发了一种可弯曲的、球囊搭载的线圈支架，目前这些问题限制了经皮腔内冠状动脉成形术的安全性和有效性。该装置由0.006英寸的不锈钢缝合材料制成，安装在直径为2.5 - 4.5毫米的球囊上，用于冠状动脉循环。在犬冠状动脉中的研究结果显示出长期通畅性和稳定性，在兔动脉粥样硬化动脉中的研究表明，支架置入的后期效果可能优于单纯球囊血管成形术。初步临床研究集中于在血管闭塞时将该装置用作手术“桥梁”。该支架在此应用中似乎已取得成功。一项2期研究正在考察该支架作为特定解剖亚组患者急性血管闭塞的确定性治疗方法。长期通畅性的相关信息尚未可知。如果结果良好，将对该装置进行研究，以确定其是否能降低单纯球囊扩张未能产生最佳血流动力学结果的患者亚组中的再狭窄发生率。
