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临床试验/NCT04663074
NCT04663074已完成不适用

Prospective Register of Anatomical / Geometric Data Obtained by Intravascular Ultrasound (IVUS) Examinatio´n of Bridging Stent Grafts in Complex Aortic Interventions

University Hospital Muenster6 个研究点 分布在 4 个国家目标入组 80 人开始时间: 2020年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
6
主要终点
bSG patency

研究概览

简要总结

The study aims to investigate the applicability of intravascular ultrasound (IVUS) in the endovascular therapy of juxta-, supra- and thoracoabdominal aortic aneurysms.

The focus of the study is on the intraoperative and postoperative evaluation of the geometric data of bridging stentgrafts in terms of patency, occurrence of stenosis and/or kinking.

详细描述

Intravascular ultrasound (IVUS) is an already validated diagnostic method increasingly use in endovascular interventions. In contrast to conventional digital subtraction angiography (DSA), the IVUS provides in vivo real-time vessel images. Furthermore, its accuracy has been examined in histological studies, which could report of a good correlation regarding the vessel diameters (Jin ZG et al. Int J Cardiovasc Imaging. 2017 Feb; 33 (2): 153-160.).

Stenosis and/or kinkings of stents or stentgrafts as well as their fully expansion and morphology can be assessed with the use of IVUS.

The IVUS has already been used successfully in the context of endovascular treatment of infrarenal aortic aneurysms (Endovascular Aortic Repair or EVAR). Here, the IVUS has proven to be a valuable diagnostic instrument to examine the anatomy of the inserted stent grafts intraoperatively and to detect any abnormalities. In addition, the use of IVUS led to a significant reduction in the use of iodine-containing contrast media and radiation exposure as part of these complex endovascular interventions (Pecoraro F et al. Ann Vasc Surg. 2019 Apr; 56: 209-215.).

In the endovascular therapy of thoracoabdominal as well as suprarenal and juxtarenal aortic aneurysms, stent grafts with recesses (windows - Fenestrated EVAR or FEVAR) or side arms (branches - Branched EVAR or BEVAR) for the renovisceral vessels (truncus coeliacus, superior mesenteric artery and renal arteries) are implanted. In exceptional cases, the renovisceral vessels are supplied with stent grafts that are implanted in parallel to the aortic stent grafts (Chimney-Technique). These branches or windows are then connected to the corresponding target vessels via a bridging stent graft. The patency and anatomy of the bridging stent grafts are usually checked intraoperatively by angiography. The dynamics of the contrast agent flow and the X-ray images of the framework of the stent graft help in assessing their patency as well as the absence of structural problems.

The Computed Tomographic Angiography (CTA) is considered the gold standard as diagnostic method to assess the patency and anatomy of the stentgrafts postoperatively. This diagnostic method bares with it the exposure to relevant radiation dose as well as to contrast media. However, CTA scans do not provide in vivo real-time vessel images.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age over 18 years
  • Elective or emergency treatment of an aortic aneurysm with a branched or fenestrated stent graft or with the aid of parallel stent grafts´(chimney)
  • Patient capable of giving informed consent

排除标准

  • Patients who are already participating in another study
  • child bearing or breast feeding females

结局指标

主要结局

bSG patency

时间窗: 5 years

Patency of the bridging stentgraft

次要结局

  • Geometrical changes(5 years)

研究者

发起方
University Hospital Muenster
申办方类型
Other
责任方
Sponsor

研究点 (6)

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