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临床试验/NCT05590182
NCT05590182已完成不适用

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

Jena University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年9月1日最近更新:
适应症
干预措施

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

Active Comparator

CO2-enhanced angiography

干预措施: Angiography (Device)

iodine CM first/ CO2 second

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

René Aschenbach

Head Interventional Radiology,

Jena University Hospital

研究点 (1)

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