跳至主要内容
临床试验/NCT00680004
NCT00680004Unknown不适用

The Value of Dynamic CTA During the Follow-up of EndoVascular Aortic Replacement (EVAR): a Pilot Study

Radboud University Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
to quantitatively characterize the stresses and forces on an implanted endograft during the cardiac cycle in terms of longitudinal movement

研究概览

简要总结

This pilot study aims to quantitatively characterize the stresses and forces on an implanted endograft during the cardiac cycle in patients scheduled for standard endograft follow-up. The developed techniques will be applied in future studies for characterizing and comparing the currently commercially available endografts so as to gain insight into the mechanisms underlying potential endograft failure. In addition, to assist in developing endografts with long-term durability and functioning characteristics for the benefit of the patient

详细描述

Endovascular Aortic replacement (EVAR) for the treatment of aortic aneurysms in patients at risk of aneurysm rupture is an established endovascular technique (ref: Blankensteijn, NEJM, 2005). However, the development of the endograft design is ongoing in order to prevent late endograft failure (e.g. graft breakage, graft displacement). The stresses and forces applied to the endograft by the high physiological forces and stresses in the aorta have an effect on the durability and functioning of the endograft. The stresses and forces that occur during movement may be reflected by movement of the endograft itself during the cardiac cycle. Standard patient follow-up involves transverse CT imaging to detect endograft leakage. However, transverse imaging does not provide information on endograft displacement but does provide information on shrinkage of the aneurysm after endograft placement. Therefore, additional information on the longitudinal displacement of the endograft during the cardiac cycle may assist in determining the optimal characteristics of a durable endograft and therefore benefit the patient in the long-term. Evaluation of the stresses and forces by calculating longitudinal displacement of the endograft appears possible by applying a cardiac CT technique, namely, dynamic CTA (computed tomography angiography), on an endovascular device. To our knowledge, this new approach will yield new in vivo data on endograft behavior.

This pilot study aims to quantitatively characterize the stresses and forces on an implanted endograft during the cardiac cycle in patients scheduled for standard endograft follow-up. In addition, in order to have the possibility to compare the movement of the aorta pre- and post-endograft placement, the aorta of patients planned for an endograft implantation procedure and who are thus already planned to undergo a clinical CT will also instead be scanned using ECG gated dynamic CTprotocol.

The developed techniques will be applied in future studies for characterizing and comparing the currently commercially available endografts so as to gain insight into the mechanisms underlying potential endograft failure, and in addition, to assist in developing endografts with long-term durability and functioning characteristics for the benefit of the patient.

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

  • Preoperative patients planned for a CT prior to an endograft implantation procedure
  • Patients who underwent a complicated endograft implant and/or with increased risk of complications
  • 18 years of age or older
  • Patients who have given their informed consent

排除标准

  • Known allergy for contrast medium

结局指标

主要结局

to quantitatively characterize the stresses and forces on an implanted endograft during the cardiac cycle in terms of longitudinal movement

次要结局

  • evaluate the integrity of the endograft by visualization using CT in the longitudinal and transversal plane at several moments during the cardiac cycle versus the standard transverse plane method

研究者

申办方类型
Other

研究点 (1)

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