Zenith® Fenestrated+ Endovascular Graft Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 44
- 主要终点
- Composite measure of device technical success and procedural safety
研究概览
简要总结
The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2 for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries.
Up to 60 additional subjects may be enrolled in Continued Access phase of the study
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
- •Include Criteria:
- •Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 55 mm for males and ≥ 50 mm for females
- •Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months
- •Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with aortic diameter > 2x the normal aortic diameter or saccular aneurysm that warrants treatment in the opinion of the investigator
排除标准
- •Age < 18 years
- •Life expectancy < 2 years
- •Pregnant, breast-feeding, or planning to become pregnant within 60 months
- •Inability or refusal to give informed consent by the patient or legally authorized representative
- •Unwilling or unable to comply with the follow-up schedule, required clinical assessments, and imaging
- •Simultaneous participation in another investigation study, unless the patient is at least 30 days beyond the primary endpoint of any previous study
研究组 & 干预措施
Aortic abdominal aneurysm
干预措施: Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2 (Device)
结局指标
主要结局
Composite measure of device technical success and procedural safety
时间窗: 30 days post procedure
Percent of patients with device technical success and freedom from procedural safety events in the following criteria: 1. Device technical success which includes delivery, deployment, and withdrawal of the device without the need for unanticipated corrective intervention), and 2. Freedom from the following procedural safety events: rupture, aneurysm-related mortality, permanent paraplegia, new onset renal failure requiring dialysis, bowel ischemia requiring surgery, and disabling stroke
Composite measure of freedom from aneurysm-related mortality and clinically significant reintervention
时间窗: 12 months post procedure
Percent of patients meeting the following criteria: 1. Freedom from aneurysm-related mortality (death from aneurysm rupture, death from any cause occurring within 30 days of procedure or secondary intervention or device or procedure related death) and 2. Freedom from clinically significant reintervention (including open surgery to restore blood flow or restore bodily function, any device related intervention requiring hospitalization, placement of an additional endovascular graft component(s), placement of a stent(s) as indicated for loss of or for having inadequate fixation, seal or patency)
次要结局
未报告次要终点