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临床试验/NCT07475260
NCT07475260尚未招募不适用

Investigating the Influence of Cardiac and Respiratory Pulsatility Deformation on the Abdominal Aorta Before and After the Implantation of the Fenestrated TREO.

University of Twente6 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2026年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
25
试验地点
6
主要终点
Proportion of patients who experience treatment success.

研究概览

简要总结

This is a national multicenter study with 25 patients with a complex AAA undergoing endovascular repair with the Fenestrated TREO™ stent graft. ECG and respiratory-gated CT scans will be performed pre-operatively, at discharge, after 6 months, and after 12 months follow up. If stent movement is still present in after 12 months, then another scan will be taken at 24 months. To include respiratory gated with the ECG-gated, patients will undergo ECG-gated CT scan during an inspiration breath-hold as well as an expiration breath-hold. This double gated CT scans will allow us to analyse the movement of the stent graft caused by the cardiac cycle and respiratory cycle.

The duration of this study is 2.5 years.

详细描述

Fenestrated endovascular aortic repair (F-EVAR) uses stent grafts with customized fenestrations to treat complex aortic aneurysms in patients at risk of aneurysm rupture. The long-term durability of these stent grafts is hindered by complications requiring reintervention. Especially the perirenal fixation and sealing area is of vital importance. The customized fenestrations in the stent graft are cannulated with stents into the renal and/or mesenteric arteries, challenging the perirenal fixation. Once implanted, the aorta dynamics and the device affect each other in ways that are currently not understood. Pre and post- operative imaging of aortic aneurysm is routinely performed using computerized tomographic angiography (CTA). However, these static techniques do not consider the aorta dynamics. Consequently, our understanding of the dynamic behavior of the stent graft and stented target vessels is limited. ECG-gated CTA is a technique that takes the patient's heart cycle into account and taking the ECG-gated CTA during inspiration and during expiration takes the patients respiratory motion into account, creating a double gated CT scan. This double gated CTA enables studying the motion of aorta and implanted devices.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Asymptomatic AAA,
  • Age > 65
  • Indication for AAA treatment according to standard practice
  • Anatomic suitability for the fenestrated Treo stent graft
  • At least one stentable main renal artery and one other stentable renal or mesenteric artery
  • Being able to hold their breath for 10 seconds.

排除标准

  • No informed consent obtained
  • eGFR < 30 ml/min
  • Allergy for intra venous contrast fluid.

研究组 & 干预措施

Complex AAA Patients

The entire cohort consists of patients with an abdominal aortic aneurysm eligible for fenestrated endovascular aortic repair using a fenestrated Treo device.

干预措施: CT scan (Diagnostic Test)

结局指标

主要结局

Proportion of patients who experience treatment success.

时间窗: One year post procedure.

Treatment success is defined as freedom from the following: Type I and III endoleak; stent graft migration; AAA enlargement; AAA rupture; conversion to open surgery; significant twists, kinks or obstruction; aneurysm-related patient death.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elke Hestermann

Coordinating Investigator

University of Twente

研究点 (6)

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