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临床试验/NCT03469245
NCT03469245已完成不适用

Validation of Fenestrations Positioning by Numerical Simulation in Fenestrated Endovascular Repair of Abdominal Aortic Aneurysms

Centre Hospitalier Universitaire de Saint Etienne9 个研究点 分布在 5 个国家目标入组 50 人开始时间: 2018年4月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
9
主要终点
Vascutek in vitro validation test and the numerical simulation

研究概览

简要总结

Fenestrated endovascular repair (FEVAR) is nowadays a recognized option to treat juxtarenal, pararenal or suprarenal abdominal aortic aneurysms in patients at high risk for conventional repair. The technique consists in deploying a custom-made stent-graft (SG) inside the patient aorta. Part of the customization involves cauterizing a hole in SG fabric and reinforcing it with a Nitinol stent ring, thereby creating a fenestration for each corresponding collateral artery. For this reason, preoperative planning is crucial to determine adequate positions of fenestrations, in order to obtain perfect alignment with the collateral arteries of the patient. Inadequate positioning may result in failure to catheterize a collateral artery and subsequent organ damage, increased catheterizing time, increased irradiation dose, endoleaks... The current process of fenestrations positioning for fenestrated anacondaTM SG involves: (i) anatomical measurements on patient preoperative CT-scan by case planners using dedicated sizing software; (ii) designing an initial custom device scheme with its positioned fenestrations, created by engineers with CAD software using the above cited measurements and (iii) validation of fenestrations position by in vitro testing using a SG prototype deployed inside a transparent anatomy model (3D-printed model of patient aorta and collateral arteries). The main limitations of this process are the costs and long SG delivery time.

详细描述

The current process of fenestrations positioning for fenestrated anacondaTM SG involves: (i) anatomical measurements on patient preoperative CT-scan by case planners using dedicated sizing software; (ii) designing an initial custom device scheme with its positioned fenestrations, created by engineers with CAD software using the above cited measurements and (iii) validation of fenestrations position by in vitro testing using a SG prototype deployed inside a transparent anatomy model (3D-printed model of patient aorta and collateral arteries). The main limitations of this process are the costs and long SG delivery time.

The goal of this study is to compare fenestrations positioning obtained by two different processes, the actual one at Vascutek and the one by numerical simulation performed by Predisurge company.

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

  • abdominal aortic aneurysms suitable for treatment using Fenestrated AnacondaTM (Vascutek) device

排除标准

  • failure to generate an adequate FE model of patient arteries (no preoperative multidetector contrast-enhanced CT-scan available, preoperative CT-scan slice thickness greater than 1mm, preoperative CT-scan with artifacts)
  • stent-graft setup implanted during the surgical procedure has been modified compared to preoperative planning
  • patient refusing to participate to the study

结局指标

主要结局

Vascutek in vitro validation test and the numerical simulation

时间窗: Months: 18

To compare Vascutek in vitro validation test and the numerical simulation (Predisurge). The proportion of fenestrations is less or equal to 2.5mm will be calculated.

次要结局

  • initial and final stent-graft designs obtained from Vascutek(Months: 18)
  • stent-graft designs obtained from simulation of deployment(Months: 18)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (9)

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