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临床试验/NCT06103942
NCT06103942尚未招募不适用

Automated Carbon Dioxide Angiography in Comparison to Iodinated Contrast Medium Angiography During Fenestrated/Branched Endovascular Abdominal Aortic Aneurysm Repair (F/B-EVAR)

Uppsala University0 个研究点目标入组 30 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
主要终点
Technical success

研究概览

简要总结

Carbon Dioxide (CO2)-based angiography is a digital subtraction angiography (DSA), where CO2 is used as an intra-arterial contrast agent.

Now, with the availability of an automated CO2 injector system (Angiodroid Srl, Italy) and the improvement in image acquisition protocols, CO2 angiography is increasingly used for vascular imaging and endovascular procedures.

Fenestrated and branched endovascular aortic repair (F/B-EVAR) for thoracoabdominal aortic aneurysms (TAAAs) is nowadays considered the treatment of first choice, due to its reduced procedure-related morbidity and mortality, when compared to open repair.

A peculiarity of these procedures is the need of high volumes of contrast media, which are not needed in case of open repair. This increases the related risk of impaired kidney function at the short- and long-term.

The present study will specifically examine the safety of the use of CO2 as intra-arterial contrast agent using the Angiodroid automated CO2-injection system during F/B-EVAR procedures. Furthermore, the current study will focus on image quality during the different steps of the procedure with the aim of standardize injection parameters (volume and pressure) for the detection of the ostium of the visceral vessels as well as of the iliac arteries, all defined as target vessels.

详细描述

Carbon Dioxide (CO2)-based angiography is a digital subtraction angiography (DSA), where CO2 is used as an intra-arterial contrast agent. This practice started in 1970s and it is commonly used for patients who have an impaired renal function, allergy to iodinated contrast media (ICM) or that could have a contrast-induced nephropathy (CIN) risk.

Carbon dioxide is an effective and low-risk alternative to ICM, which is nowadays used in endovascular procedures, thanks to its unique properties, such as no risk for nephrotoxicity or allergic reaction. For many years, the two most important restrictions for this technique consisted of: 1) the absence of a delivery system that could minimize the risk of air contamination during the CO2 angiography and allow controlled injection (in terms of pressure and volume of injection) of the CO2 and 2) the absence of a customized imaging protocol for a better visualization of CO2 during DSA acquisition.

Now, with the availability of an automated CO2 injector system (Angiodroid Srl, Italy) and the improvement in image acquisition protocols, CO2 angiography is increasingly used for vascular imaging and endovascular procedures.

Fenestrated and branched endovascular aortic repair (F/B-EVAR) for thoracoabdominal aortic aneurysms (TAAAs) is nowadays considered the treatment of first choice, due to its reduced procedure-related morbidity and mortality, when compared to open repair.

A peculiarity of these procedures is the need of high volumes of contrast media, which are not needed in case of open repair. This increases the related risk of impaired kidney function at the short- and long-term.

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 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with indication for treatment of complex TAAA according to accepted international guidelines
  • Provided informed consent

排除标准

  • Severe COPD (Chronic Obstructive Pulmonary Disease), GOLD Stage 3 and 4
  • Known atrium- or ventricular septal defect with right-left-shunt
  • Current participation in other interventional studies

结局指标

主要结局

Technical success

时间窗: at the time the intervention

Technical success in terms of detecting the ostium of the visceral vessels as well as of the hypogastric arteries (defined as 100% accuracy when compared to the iodinated contrast agent angiography)

CO2 sensitivity and specificity compared to iodinated contrast agent angiography

时间窗: at the time the intervention

CO2 sensitivity and specificity compared to iodinated contrast agent angiography in detecting dissections, stenosis, occlusions or bleeding of the target vessel. The comparison will be blinded and retrospective.

次要结局

  • Image quality(at the time the intervention)

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Sponsor

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