Prospective, Single-arm, Single Center, Pilot Study of Vascular Ultrasound Imaging Used as an Adjunct to Intravascular Ultrasound for Diagnosing Iliac Vein Obstruction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- A composite of direct and indirect ultrasonographic signs as a measure of iliac vein stenosis
研究概览
简要总结
- Determine the sensitivity, specificity and accuracy of vascular ultrasound, using direct and indirect ultrasonographic signs, in the obstructive diseases of iliac venous segment, in patients with advanced chronic venous insufficiency (CEAP 3-6), considering the intravascular ultrasound (IVUS) as the gold standard for this diagnosis.
- Develop an algorithm for noninvasive ultrasound investigation of obstructive lesions in the iliac segment in patients with advanced chronic venous insufficiency (CEAP 3-6).
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced Chronic Venous Insufficiency (CEAP 3-6) submitted to clinical treatment for at least 1 year with no response.
- •Subject must be > 18 and < 80 years of age
- •Willing to participate in and able to understand, read and sign the informed consent document before the planned procedure
- •On duplex ultrasound: patent common femoral vein, and patent deep femoral vein, and/or femoral vein of the study leg
排除标准
- •Subject cannot or will not provide written informed consent
- •Previous venous stent implantation involving the study leg or inferior vena cava
- •Previous venovenous bypass surgery involving the study leg
- •Known reaction or sensitivity to iodinated contrast that cannot be managed with premedication
- •Subjects who are pregnant (women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment
- •Acute deep venous thrombosis involving either leg
- •Known history of chronic total occlusion of the common femoral vein of the study leg.
- •Known history of thrombophilia (e.g., protein C or S deficiency, anti-thrombin III deficiency, presence of lupus anticoagulant, etc.)
- •Venous compression caused by tumor encasement
- •Venous outflow obstruction caused by tumor thrombus
- •Life expectancy of less than 6 months
- •Lower Extremity Arterial Insufficiency
- •Elevated baseline blood creatinine (value greater than the upper limit of the normal range)
- •Any concurrent disease or condition that, in the opinion of the Investigator, would make the subject unsuitable for participation in the study; examples include but are not limited to the inability to lie supine for the index procedure (e.g., severe congestive heart failure), thrombocytopenia or other hematological disorders associated with an unacceptable risk of bleeding, implanted orthopedic hardware that precludes proper imaging, etc.
结局指标
主要结局
A composite of direct and indirect ultrasonographic signs as a measure of iliac vein stenosis
时间窗: within 15 days
• 50 patients with Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) classification C3-6 undergoing iliac and common femoral vascular ultrasound imaging with intention to detect significative iliac vein obstructions ( \> 50%) and this results will be compared with the gold standard method - IVUS. Primary Endpoints: venous imaging in B- mode, volume flow and expiratory velocity in femoral vein, and the velocity relation before and through the stenosis provided by vascular ultrasound will be analyzed. Venous IVUS will provide measurements of minimum and maximum diameter reduction due to iliofemoral venous obstruction/compression; cross-sectional area reduction will also be measured. The percentage of significant stenosis detected at various thresholds \[ \< 50%, 50-80%,\> 80%\] with each method will be compared in a pair-wise fashion. This will be done with descriptive statistics of the detection rates for each method, and the rate of discordance between the two.
次要结局
未报告次要终点
研究者
Fabio H Rossi
PHD
Instituto Dante Pazzanese de Cardiologia