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临床试验/NCT01230684
NCT01230684终止不适用

Comparison of Contrast Enhanced Ultrasound and the Gold Standard Computed Tomographic Angiography in Detection of Endoleak Following Endovascular Abdominal Aortic Aneurysm Repair.

University of Michigan2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2010年12月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
2
主要终点
Patient diagnosed with endoleak via CEUS and confirmed by CTA

研究概览

简要总结

The purpose of the study is to compare two different types of imaging techniques to identify endoleaks. Following the endovascular procedure, subjects are seen at one month to have computed tomographic angiography (CTA) to confirm the graft is not leaking (endoleak). CTA is the standard imaging technique used to identify endoleaks. This study will investigate if the image technique color duplex ultrasound with contrast enhanced ultrasound (CEUS) is a good tool to identify endoleaks too.

详细描述

Background:

Abdominal aortic aneurysms (AAAs) continue to be a leading cause of death in older age groups. In the 60-85 year-old population, AAA represents the 14th-leading cause of death. Federal funding through Medicare has been allocated for early detection using abdominal ultrasound screening programs. Despite these more aggressive screening programs and concerted efforts by surgeons for timely repair, the incidence of ruptured AAA has continued to increase.

Endovascular aneurysm repair (EVAR) has been the most common type of repair since 2006. Multiple studies reflecting decreased perioperative morbidity and mortality over open repair make this an attractive option for patients. EVAR requires more intensive follow-up than standard open surgical repair, however. Secondary interventions are more common to maintain "seal" of the endograft within the aorta and subsequent exclusion of the aneurysmal component.

The term endoleak is specific to EVAR, and describes the primary means by which endografts fail. Type I endoleaks occur because of inadequate graft seal proximally or distally, resulting in perigraft flow and aneurysm sac pressurization. Type II endoleaks occur when branch arteries arising from the aneurysmal aorta back-bleed into the aneurysm sac due to collateral flow. Type III endoleaks occur when flow persists between segments of a modular graft. Type IV endoleaks occur when flow persists through endograft material (graft porosity). Type V endoleaks have also been called "endotension", and occur when pressurization of the sac occurs in the absence of any demonstrable endoleak. Type I and Type III endoleaks are most concerning for rupture, although persistent Type II endoleaks can also lead to aneurysm rupture and premature death.

The most common method of EVAR follow-up is computed tomographic angiography (CTA). These studies allow accurate measurement of aneurysm sac diameters and volumes. They also are highly sensitive and specific for endoleaks. Type II endoleaks are treated if they remain persistent and are present in the setting of aneurysm sac enlargement. Type I and III endoleaks are immediately treated when identified. Type IV endoleaks are rarely seen with current endograft technology.

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

  • 18 years old and greater
  • Men or postmenopausal/non-pregnant women
  • Abdominal aortic aneurysm successfully repaired by endograft deployment
  • Creatinine < 2.0 mL
  • Planned CTA follow-up

排除标准

  • Subjects with known or suspected hypersensitivity to blood, blood products, or albumin.
  • Subjects unable/unwilling to give informed consent
  • Unable to complete post-operative imaging studies
  • Subjects identified to have a cardiac shunt by TTE
  • Subjects with hepatic or respiratory disease
  • Nursing mothers

结局指标

主要结局

Patient diagnosed with endoleak via CEUS and confirmed by CTA

时间窗: 30 days postoperative visit

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

Jonathan Eliason

MD

University of Michigan

研究点 (2)

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