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临床试验/NCT04444999
NCT04444999Unknown不适用

Carbon Dioxide Guided Angiography in Endovascular Abdominal Aortic Aneurysm Repair

Mansoura University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Validity of Carbon Dioxide angiography in Visualizing of Renal and hypogastric arteries.

研究概览

简要总结

Endovascular aneurysm repair (EVAR) has lower short-term morbidity and mortality than open surgery. Intra-arterial contrast agents are an important component of successful EVAR as the tool of choice for preoperative evaluation of aortic aneurysm morphology as well as precise sizing and intraoperative visualization of the ostia of the renal and hypogastric arteries for graft replacement. Although iodinated contrast (IC) is overwhelmingly the most common contrast agent, the perioperative use of IC agents is not recommended in patients with renal dysfunction or allergies to IC The aim of this study was to evaluate feasibility, efficacy and safety of carbon dioxide (CO2) digital subtraction angiography (DSA) to guide endovascular aneurysm repair (EVAR) in a cohort of patients with abdominal aortic aneurysm

详细描述

INTRODUCTION:

Endovascular aneurysm repair (EVAR) has lower short-term morbidity and mortality than open surgery. Intra-arterial contrast agents are an important component of successful EVAR as the tool of choice for preoperative evaluation of aortic aneurysm morphology as well as precise sizing and intraoperative visualization of the ostia of the renal and hypogastric arteries for graft replacement. Although iodinated contrast (IC) is overwhelmingly the most common contrast agent, the perioperative use of IC agents is not recommended in patients with renal dysfunction or allergies to IC.

Many strategies have been proposed with the aim of reducing IC developed, such as the use of intravascular ultrasound, high-quality 3-dimensional imaging techniques, and fusion of preoperative and intraoperative imaging. However, despite reports of various methods of renal protection, including the use of perioperative hydration, acetylcysteine, mannitol, dopamine, and fenoldopam, the effects of these methods are controversial.

Carbon dioxide (CO2)-guided angiography is an alternative contrast approach first described for diagnostic purposes by Hawkins. Although many studies have demonstrated the safety and effectiveness of CO2-EVAR and its noninferiority to Iodinated Contrast Angiography during EVAR.

Intravascular ultrasound (IVUS) has been used as an alternative to IACA(intra-arterial contrast agents). Originally, IVUS images had low accuracy, but recent improvements have resulted in very high-quality images of intra-aortic structures, which makes the use of IACA(intra-arterial contrast agents) almost unnecessary. An additional advantage of IVUS is that it facilitates the precise placement of stent grafts, because it is more accurate in locating hypogastric arteries and renal arteries which have parallax from the anteroposterior (A-P) view rather than from angiography. In this study, investigators will compare Carbon Dioxide Guided Angiography in relation to Iodinated Contrast Angiography during EVAR.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Age more than 18 years old. Abdominal Aortic above Aneurysm candidate for EVAR

排除标准

  • previous abdominal aortic surgery, , mycotic aneurysm and secondary intervention

结局指标

主要结局

Validity of Carbon Dioxide angiography in Visualizing of Renal and hypogastric arteries.

时间窗: 6 months

Visualizing of Renal and hypogastric arteries.

Validity of Carbon Dioxide angiography in Visualizing Endoleaks

时间窗: 6 months

Endoleaks occur when blood leaks back into an aneurysm sac following an endovascular aneurysm repair (EVAR) procedure-one of the procedure's most common complications.

Validity of Carbon Dioxide angiography in Visualizing Neck of the aneurysm measurements.

时间窗: 6 months

measuring the supra renal and infra renal neck measurements

次要结局

  • Safety of Carbon Dioxide angiography at Endovascular aortic aneurysm repair(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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