跳至主要内容
临床试验/NCT06250998
NCT06250998招募中不适用

Prediction of Abdominal Aortic Aneurysm Shrinkage After Endovascular Repair With Artificial Intelligence

Rijnstate Hospital5 个研究点 分布在 2 个国家目标入组 1,000 人开始时间: 2024年4月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
5
主要终点
Prediction model for AAA shrinkage

研究概览

简要总结

The goal of this observational study is to find out what factors contribute to a good treatment outcome in patients who have received a stent for their dilation of the main abdominal artery (abdominal aortic aneurysm or AAA). The primary goal of this study is to build a prediction model for abdominal aortic aneurysm shrinkage one year after the treatment.

研究设计

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

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

  • Age ≥ 18 years;
  • Elective, initially technically successful (as described by the ESVS guidelines11), infrarenal EVAR for unruptured infrarenal AAA;
  • Implanted endograft is a Gore Excluder, Medtronic Endurant, Cook Zenith, Cordis Incraft, Endologix AFX, Jotec E-Tegra, or Vascutek Anaconda endograft;
  • Follow-up of the AAA of at least one year with imaging of the same modality as the preoperative imaging;
  • Axial reconstructions of preoperative CT angiography available, preferably in the arterial phase and with 3 mm or smaller slice thickness.

排除标准

  • Patients with ruptured or symptomatic AAA;
  • Patients that were treated with fenestrated or branched endografts, iliac branched devices, non-CE marked devices within trial setting, other endografts (EVAS cases) or chimney procedures;
  • Acute procedures;
  • Reintervention before one year follow-up;
  • Revision cases after previous open or endovascular aneurysm repair of an AAA;

结局指标

主要结局

Prediction model for AAA shrinkage

时间窗: Preoperative, peroperative and postoperative (until 1-year visit) data

A prediction model to predict AAA shrinkage one-year after EVAR, it can consist of multiple CTA-scans and/or clinical data.

次要结局

未报告次要终点

研究者

发起方
Rijnstate Hospital
申办方类型
Other
责任方
Sponsor

研究点 (5)

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