Evaluation of Contrast-Enhanced Ultrasound to Detect Endoleaks After Endovascular Aortic Aneurysm Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Endoleak Detection
研究概览
简要总结
This study will be a cross-sectional survey of interobserver variability associated with contrast enhanced ultrasound (CEUS) to detect endoleaks using computed tomographic angiography (CTA) as the practice standard. The investigators will enroll 40 consecutive patients undergoing endovascular abdominal aortic aneurysm repair (EVAR). At the first follow-up visit after the procedure, participants will undergo two abdominal ultrasound examinations with and without contrast, and one CTA. Analyses will be conducted to examine interobserver variability in the detection and characterization of endoleaks using contrast-enhanced ultrasound (CEUS). Other endpoints include examination of sensitivity and specificity of CEUS compared to CTA, and characterization of the number and types of endoleaks detected.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Age 18 years of age or greater;
- •Diagnosed with abdominal aortic aneurysm and has undergone or is scheduled to undergo endovascular repair procedure.
- •Has not completed the first scheduled post-treatment follow-up exam
- •Voluntary participation and signature of IRB-approved informed consent.
排除标准
- •Inability to consent (includes non-English speaking patients)
- •Has already completed the first scheduled post-treatment follow-up exam.
- •Clinical instability;
- •Pregnancy / breast feeding;
- •Known allergy to perflutren;
- •Known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts (based on manufacturer recommendations for use);
- •Recent heart attack (<6 months), unstable angina or uncontrolled cardiopulmonary disease
- •Clinically unstable or recent worsening congestive heart failure (based on FDA warning)
- •Serious ventricular arrhythmias or at high risk for arrhythmias
- •Respiratory failure (based on FDA warning)
- •Severe emphysema, pulmonary emboli or other conditions that compromise pulmonary arterial vasculature (based on FDA warning)
- •Any reason judged by the investigators to hamper inclusion.
结局指标
主要结局
Endoleak Detection
时间窗: Same day outcome
Persistent of a pulsatile intrasac color flow outside the stent-graft
次要结局
未报告次要终点
研究者
E. Peden, MD
Sponsor-Investigator/Principal Investigator
The Methodist Hospital Research Institute