Endovascular Repair of Juxtarenal Aortic Aneurysm
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- The primary outcome measure will be clinical success .
研究概览
简要总结
The investigators compare different endovascular techniques as an alternative to surgical reconstruction to repair JAAS regarding ; success rates, 30-day mortality,endoleak events secondary intervention rates
详细描述
Aortic disease is the direct cause of close to 10000 deaths annually in the United States. 1
Aneurysmal disease can affect any segment of the aorta, from the aortic root to the aortic bifurcation. Juxtarenal Aortic Aneurysms (JAA) (where a specialty designed custom -made device (endograft)which has holes, or fenestrations ,on the graft body to maintain the patency of the visceral arteries) account for approximately 15% of abdominal aortic aneurysms.2
Successful aortic aneurysm treatment depends on either open replacement or endovascular exclusion of the aneurysmal segment with healthy artery proximal and distal to the repair.
The decision to treat an AAA is based on the associated risk of treatment, the risk of aneurysm rupture, the patient's life expectancy, and patient preference.
The primary determinant of rupture risk is maximum aneurysm diameter, with negligible rupture risk in aneurysms <4cm in diameter compared with aneurysms >8 cm . 3, 4.
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
- 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
- •• Subject is ≥18 years old
- •Subject is scheduled for treatment of the juxtarenal aortic aneurysm with a short infrarenal neck aortic neck length <15 mm, neck angulation >60%, conical neck) (i.e. denovo cases).
- •Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements.
- •Subject has provided written informed consent.
排除标准
- •Subject is participating in a concurrent study which may confound study results
- •Subject has a life expectancy ≤1 year
- •Subject has an aneurysm that is:
- •Inflammatory
- •Pseudoaneurysm
- •Subject requires emergent aneurysm treatment, for example, trauma or rupture
- •Subject has previously undergone surgical treatment for abdominal aortic aneurysm
- •Subject is a female of childbearing potential in whom pregnancy cannot be excluded
- •Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment.
结局指标
主要结局
The primary outcome measure will be clinical success .
时间窗: One year
Clinical success will be evaluated by Measurment of blood pressure by sphygmomanometer in mmhg Serum creatinine level in mg/dL
One year patency of the endovascular graft
时间窗: One year
One year patency will be assessed by CT angiography ( if it is patent or not). CT angiography can detect successful deployment of the endovascular device at the intended location or post endograft complications as type I or III endoleak , graft thrombosis, aneurysm expansion , aneurysm rupture.
次要结局
未报告次要终点
研究者
Khaled Mohamed Awad Hassan
Assistant lecturer
Assiut University