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临床试验/NCT01744119
NCT01744119终止不适用

Vascutek Anaconda™ Stent Graft System for Infra-Renal Abdominal Aortic Aneurysm Repair

Vascutek Ltd.21 个研究点 分布在 7 个国家目标入组 318 人开始时间: 2005年4月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
318
试验地点
21
主要终点
Evaluation of graft performance

研究概览

简要总结

The purpose of this observational Post-Market Surveillance Registry is to gather post-market data on the performance of the CE marked Vascutek Anaconda™ Stent Graft System for the repair of Abdominal Aortic Aneurysms (AAA). The Study population consists of patients suitable for endovascular repair of AAA. Patients will be followed at 1, 3, 6, 12, 18, 24, 36, 48 and 60 months post-implantation.

详细描述

Vascutek Limited, a world leader in the development of vascular grafts, has combined their latest technological developments in polyester textile technology with unique endovascular design features to produce Anaconda™, the world's next generation of AAA stent graft systems. Intuitive and of a modular design, Anaconda™ is the only repositionable device which also features exceptional flexibility. The modular design comprises bifurcate bodies, iliac legs and aortic cuffs. Nitinol, an alloy of nickel and titanium, has self-expanding properties and forms the top "ring-stent" of the bifurcate body section. The "ring stent" is composed of multiple turns of Nitinol wire that provides significantly increased "hoop-strength" enabling a conformable and secure haemostatic seal against the vessel wall to be achieved. Nitinol hooks located adjacent to the "ring stent" anchor the graft in position thus preventing graft migration. The iliac limbs are fully supported with Nitinol and the bifurcate bodies feature a distal contra-lateral lumen Nitinol support, which in conjunction with a unique intrinsic magnet guidewire system facilitates cannulation of the bifurcate section.

The system is available in a wide range of sizes thus making it a flexible and adaptable stent graft system with the potential to repair diverse patient anatomy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient is implanted with Anaconda™ Stent Graft System

排除标准

  • Ruptured or symptomatic aneurysm
  • Juxta or Suprarenal extension of aneurysm
  • Clinically serious concomitant medical disease or infection
  • Need to sacrifice both Internal Iliac Arteries due to aneurysmal dilatation
  • Connective Tissue Disease (Marfan's Syndrome)
  • ASA Rating of Grade IV or V
  • Known allergy to Nitinol, Polyester or contrast medium
  • Excessive tortuosity of access vessels (femoral or iliac arteries)
  • Patients with aneurysm neck lengths of less than 15mm

结局指标

主要结局

Evaluation of graft performance

时间窗: 60 months

Data will be collected and analysed on system insertion and difficulty during deployment. Efficiency of the magnet system including magnet selection, ease of use and removal of magnet guidewire will also be evaluated.

Graft patency

时间窗: 60 months

Data will be collected and analysed on endoleak exclusion and graft migration rates

Exclusion of aneurysm

时间窗: 60 months

次要结局

未报告次要终点

研究者

发起方
Vascutek Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (21)

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