Randomized-Controlled Study to Evaluate the Diagnostic Quality and Safety of Automated Carbon Dioxide Angiography (ACDA) With a Robot-supported Angiography System in Combination With a CO2-Injector System in Patients With Peripheral Arterial Occlusive Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Degree of stenosis
研究概览
简要总结
This randomized study focuses on the diagnostic quality and safety of CO2 application as contrast medium through an innovative injector of AngioDroid in angiography interventions in patients with peripheral arterial occlusive diseases.
详细描述
CO2-angiography was used as an intra-arterial contrast agent since the 1970s particularly in patients who were hypersensitive to iodinated contrast material or whose renal function was compromised. It is in fact an effective and low-risk alternative to iodine-enhanced conventional angiography because it is not associated with nephrotoxicity or allergic reactions. The image quality influencing the diagnostic validity seems to be a restriction. Now, with the availability of high-resolution DSA and a reliable gas delivery system, CO2 angiography is more and more widely used for vascular imaging and endovascular procedures. Our study will specifically examine the image quality and safety of carbon dioxide gas as intra-arterial contrast agent using the innovative Artis Zeego Q angiography-system of Siemens Healthineers with the automated CO2-injection system of Angiodroid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Age > 18 years
- •Male, female
- •Patients with indication for percutaneous transluminal angioplasty of iliacal- or femoropopliteal arteries
排除标准
- •Children and adolescents < 18 years
- •Diagnostic angiography, CT- or MRI-angiography during the past 3 months
- •Patients with reduced renal function (S-creatinine > 1,2 mg/dl)
- •Incapacitated patients
- •Severe COPD
- •Known atrium- or ventricular septal defect with right-left-shunt
- •Current participation in other interventional studies
研究组 & 干预措施
CO2 first/ iodine CM second
CO2-enhanced angiography
干预措施: Angiography (Device)
iodine CM first/ CO2 second
iodine contrast media-enhanced angiography
干预措施: Angiography (Device)
结局指标
主要结局
Degree of stenosis
时间窗: during intervention
Calculation of maximum grade of stenosis
次要结局
- Image quality(2 weeks)
- occurence of adverse events(24 hours)
研究者
René Aschenbach
Head Interventional Radiology,
Jena University Hospital
