Objective The trial was designed to evaluate the safety and performance of the ev3 Protégé TM stent in the treatment of de novo or re-stenotic common and/or internal carotid artery stenoses with adjunctive u...Objective The trial was designed to evaluate the safety and performance of the ev3 Protégé TM stent in the treatment of de novo or re-stenotic common and/or internal carotid artery stenoses with adjunctive use of a CE-marked filter embolic protection device.Methods This study was a prospective multi-center, single-arm trial. Between June and October 2003, 77 patients were enrolled in 8 investigational centers throughout Europe. The primary endpoint was the incidence of Major Neurological Events (MANE) through one month. Other endpoints were the ability to properly place the stent, and primary patency and MANE after six months. Eligible for the study were patients with a de novo or restenotic target lesion located in the common and/or internal carotid artery (>70% stenosis for asymptomatic and >50% stenosis for symptomatic patients). The ev3 Spider (Embolic Protection Filter was used in 75 of 77 cases. Results In 76 out of the 77 patients (99%), the stent could be successfully implanted with a residual stenosis ≤30% as criterion. Of the 74 patients that had a carotid ultrasound at one month follow-up, none had a re-stenosis of the target lesion. There were three MANEs during or immediately after the procedure (3.9%), two were major and one was a minor stroke. There were eight severe complications (9.1%); six of these happened during or immediately after the procedure and were related to the procedure, none was related to the device. They are resolved without sequelae. No deaths have occurred.Conclusions The Protégé stent is safe and performs well in the treatment of carotid artery stenosis. The technical success rate for placement of the Protégé stent as assessed by the residual stenosis post implant was very high and all stents were successfully deployed. The incidence of MANE was comparable with that in other recent carotid stent studies and still lower than standard CEA.展开更多
物质和属性是构建技术系统的基本要素,物质的含义太过抽象,结合实际应用,确定以材料为研究对象。材料知识在产品开发过程中发挥着重要的作用,在数据时代描述领域知识常用的方式是本体,现有的材料本体,在研究不同行业中材料及材料的属性...物质和属性是构建技术系统的基本要素,物质的含义太过抽象,结合实际应用,确定以材料为研究对象。材料知识在产品开发过程中发挥着重要的作用,在数据时代描述领域知识常用的方式是本体,现有的材料本体,在研究不同行业中材料及材料的属性应用之间的联系具有局限性。运用U-TRIZ(Unified-Theory of Inventive Problem Solving)物质属性模型设计了新的材料本体模型。首先,基于U-TRIZ物质属性模型,综合相关著作和文献对现有的材料及材料属性进行分类,参考国民经济行业分类标准对制造业的分类进行概念提取。其次,建立概念之间的关系,形成概念模型。最后,通过半自动化的方式,运用本体构建工具Protégé构建了新的材料本体并存储。该领域本体能够发现材料、属性、属性值、行业应用之间的联系,为材料数据的充分应用与高效检索奠定基础。展开更多
文摘Objective The trial was designed to evaluate the safety and performance of the ev3 Protégé TM stent in the treatment of de novo or re-stenotic common and/or internal carotid artery stenoses with adjunctive use of a CE-marked filter embolic protection device.Methods This study was a prospective multi-center, single-arm trial. Between June and October 2003, 77 patients were enrolled in 8 investigational centers throughout Europe. The primary endpoint was the incidence of Major Neurological Events (MANE) through one month. Other endpoints were the ability to properly place the stent, and primary patency and MANE after six months. Eligible for the study were patients with a de novo or restenotic target lesion located in the common and/or internal carotid artery (>70% stenosis for asymptomatic and >50% stenosis for symptomatic patients). The ev3 Spider (Embolic Protection Filter was used in 75 of 77 cases. Results In 76 out of the 77 patients (99%), the stent could be successfully implanted with a residual stenosis ≤30% as criterion. Of the 74 patients that had a carotid ultrasound at one month follow-up, none had a re-stenosis of the target lesion. There were three MANEs during or immediately after the procedure (3.9%), two were major and one was a minor stroke. There were eight severe complications (9.1%); six of these happened during or immediately after the procedure and were related to the procedure, none was related to the device. They are resolved without sequelae. No deaths have occurred.Conclusions The Protégé stent is safe and performs well in the treatment of carotid artery stenosis. The technical success rate for placement of the Protégé stent as assessed by the residual stenosis post implant was very high and all stents were successfully deployed. The incidence of MANE was comparable with that in other recent carotid stent studies and still lower than standard CEA.
文摘物质和属性是构建技术系统的基本要素,物质的含义太过抽象,结合实际应用,确定以材料为研究对象。材料知识在产品开发过程中发挥着重要的作用,在数据时代描述领域知识常用的方式是本体,现有的材料本体,在研究不同行业中材料及材料的属性应用之间的联系具有局限性。运用U-TRIZ(Unified-Theory of Inventive Problem Solving)物质属性模型设计了新的材料本体模型。首先,基于U-TRIZ物质属性模型,综合相关著作和文献对现有的材料及材料属性进行分类,参考国民经济行业分类标准对制造业的分类进行概念提取。其次,建立概念之间的关系,形成概念模型。最后,通过半自动化的方式,运用本体构建工具Protégé构建了新的材料本体并存储。该领域本体能够发现材料、属性、属性值、行业应用之间的联系,为材料数据的充分应用与高效检索奠定基础。
