跳至主要内容
临床试验/NCT02295137
NCT02295137Unknown1 期

Image Fusion of Pre-procedural CTA With Real-time Fluoroscopy to Guide Proper Renal and Visceral Arteries Catheterization During Advanced Endovascular Aortic Aneurysms Repair: A Feasibility Study

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
1 期
入组人数
20
试验地点
2
主要终点
Procedure success

研究概览

简要总结

Abdominal Aortic Aneurysm (AAA) is a potentially life threatening condition. If the aneurysm ruptures, the mortality can be as high as 80%. Endovascular aneurysms repair (EVAR) is a minimal invasive procedure and has been widely used on treating AAA. Advanced endovascular techniques are used to treat patients with more complex pathology by using custom-made devices and additional stents. In order to accomplish the technical success on advanced EVAR, with the current imaging equipment and technique for EVAR procedures (i.e. live x-ray fluoroscopy and 2-D digital subtraction angiography (DSA)), multiple angiograms on the target arteries (arteriograms) are required. Subsequently patients are exposed to higher dose of contrast and radiation, compared to conventional EVAR. This study is to assess the feasibility of proper visceral and renal arteries catheterization using a 3D model obtained from pre-procedural computed tomographic angiography (CTA), fused with real-time fluoroscopy, without contrast injection or angiographic run-offs thus minimizing the contrast use and patient radiation exposure while achieving procedure success during Advanced EVAR.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • male or female >= 18 years;
  • scheduled for advanced EVAR for abdominal aortic aneurysm.

排除标准

  • Pregnancy;

结局指标

主要结局

Procedure success

时间窗: within 1 day

Evaluate the technical success of advanced EVAR by using pre-procedural CTA images as guidance

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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