PRESERVE-Zenith® Iliac Branch System Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 36
- 主要终点
- Patients That Are Free From Patency-related Intervention
研究概览
简要总结
The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Zenith® Connection Endovascular Stent/ConnectSX™ covered stent in the treatment of aorto-iliac 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 aortoiliac or iliac aneurysm of appropriate size
- •Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac 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
- •Unsuitable arterial anatomy
研究组 & 干预措施
Device Implant
干预措施: Endovascular repair for aortoiliac or iliac aneurysms. (Device)
结局指标
主要结局
Patients That Are Free From Patency-related Intervention
时间窗: 6 Months
Patency-related intervention is defined as: Secondary intervention to treat a \> 60% stenosis of the internal iliac artery (as identified through CT, angiography, or duplex ultrasound and confirmed by core laboratory) associated with clinical symptoms. Of note, this not only includes patients with internal iliac artery stenosis following successful placement of the Zenith® Branch Endovascular Graft-Iliac Bifurcation and ConnectSX™, but also any cases of technical failure resulting in occlusion of the internal iliac artery during the initial implant procedure that require secondary intervention for associated clinical symptoms.
次要结局
未报告次要终点