Clinical Study to Evaluate the Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 28
- 主要终点
- Number of Patients With Freedom From Patency-related Intervention Defined as a Secondary Intervention to Treat a > 60 % Stenosis of the Internal Iliac Artery Associated With Clinical Symptoms.
研究概览
简要总结
The purpose of this extended study is to evaluate the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in patients in a treatment of aortoiliac and iliac aneurysms.
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
- •An aortioiliac or iliac aneurysm
- •An unsuitable distal sealing site for a traditional Zenith iliac leg graft within the common lilac artery
排除标准
- •Less than 18 years of age
- •Inability or refusal to give informed consent
- •Disease considerations that would compromise patient safety or study outcomes
- •Pregnant, breast-feeding or planning on becoming pregnant prior to completion of the study
- •Unwilling or unable to comply with the follow-up schedule
- •Simultaneously participating in another investigative device or drug study
研究组 & 干预措施
Zenith® Branch Endovascular Graft-Iliac Bifurcation
Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft
干预措施: Zenith® Branch Endovascular Graft-Iliac Bifurcation, (Device)
Zenith® Branch Endovascular Graft-Iliac Bifurcation
Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft
干预措施: Atrium iCAST™ (Device)
Zenith® Branch Endovascular Graft-Iliac Bifurcation
Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft
干预措施: Zenith® Flex AAA Endovascular Graft (Device)
结局指标
主要结局
Number of Patients With Freedom From Patency-related Intervention Defined as a Secondary Intervention to Treat a > 60 % Stenosis of the Internal Iliac Artery Associated With Clinical Symptoms.
时间窗: 6 months
次要结局
- Freedom From Morbidity (i.e., Morbidity Index)(30 days)