Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 75
- 主要终点
- Aorfix™ vs. Open Control All Cause Mortality
研究概览
简要总结
Purpose of this study: The purpose of the study is to evaluate the safety and effectiveness of the Lombard Medical endovascular Aorfix™ AAA bifurcated stent graft in the treatment of abdominal aortic, aorto-iliac and common iliac aneurysms with anatomies including angled aorta, angled aneurysmal body, or both, between 0° and 90°.
Study hypothesis: The primary efficacy hypothesis is the proportion of grafts remaining free from endoleak, migration, and fracture at 12 months.
Efficacy: The 12 month, all cause mortality rate in the Aorfix™ group will be non-inferior to the 12 month, all cause mortality rate in the Open Control group.
Safety: The rates of early serious adverse events between 0 and 30 days post-operative in the Aorfix™ groups will be non-inferior to the early serious adverse event rates between 0 and 30 days post-operative in the Open Control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed abdominal aortic aneurysm > 4.5 cm in diameter, OR 4.0 cm or larger in diameter if symptomatic (i.e. pain, embolization), OR documented AAA growth of more than 5 mm within the previous 6 months, and/or including extension into common iliac artery (ies), and/or
- •Iliac aneurysm greater than, or equal to 3.5 cm in maximum diameter.
排除标准
- •Less than 21 years of age,
- •Life expectancy less than 2 years,
- •Pregnant,
- •Religious cultural or other objection to the receipt of blood or blood products,
- •Unwilling to comply with follow-up schedule,
- •Unwillingness or inability to provide informed consent to both trial and procedure.
- •Patients not expected to live more than 2 years from enrollment
- •Patient has a ruptured aneurysm
- •Aneurysm extends above renal arteries
- •Proximal neck of aneurysm has significant loose thrombus associated with it
- •Patient with an acute or chronic aortic dissection or mycotic aneurysm
- •Patient has current non-localized infection (may be recruited following remission of the infection)
- •Patient is allergic to device materials
- •Patient is allergic to or intolerant of use of contrast media and cannot be exposed to suitable remedial treatment such as steroids and/or benadryl
- •Patient is clinically and morbidly obese such that imaging would be severely adversely affected
- •Patient has renal failure (serum creatinine > 2.5 mg/dL)
- •Patient has an uncorrectable bleeding abnormality
- •Patient has unstable angina
- •Patient is receiving dialysis:
- •Inflammatory aneurysm
- •MI in last 6 months
- •End stage COPD
- •Patient has connective tissue disease (eg Marfan syndrome, Ehlers-Danlos syndrome)
- •Significant (>80%) renal artery stenosis which cannot be readily treated
结局指标
主要结局
Aorfix™ vs. Open Control All Cause Mortality
时间窗: 1 year
The 12 month, all cause mortality rate in the Aorfix™ group compared to all cause mortality rate in the Open Control group.
次要结局
- Aorfix™ vs. Open Control Adverse Events(30 days)