Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal Aortic Aneurysms With Fenestrated Stent Grafts
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Number of subjects who have die at 30 days post treatment
研究概览
简要总结
The purpose of this study is to evaluate clinical outcomes and quality of life measures in treated by endovascular aortic repair of juxtarenal, suprarenal, and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft.
详细描述
This is a traditional device feasibility study intended to generate preliminary safety and efficacy information that may be used to plan an appropriate future study, or to inform further product development.
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
- •General Inclusion Criteria
- •A patient may be included in the study if the patient has at least one of the following and is appropriate for treatment with a custom-made Zenith® Fenestrated AAA Endovascular Graft:
- •Juxtarenal, suprarenal or type IV thoracoabdominal aortic aneurysm with a diameter ≥ 5.0 cm or 2 times the normal aortic diameter
- •Aneurysm with a history of growth ≥ 0.5 cm per year
- •Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation.
排除标准
- •Less than 18 years of age
- •Unwilling to comply with the follow-up schedule
- •Inability or refusal to give informed consent by the patient or a legally authorized representative
- •Pregnant or breastfeeding
- •Life expectancy < 2-years
- •Additional medical restrictions as specified in the Clinical Investigation Plan
- •Additional anatomical restrictions as specified in the Clinical Investigation Plan
结局指标
主要结局
Number of subjects who have die at 30 days post treatment
时间窗: 30 days post treatment]
Deaths 30 days after treatment
Number of subjects who experience a Major Adverse Event at 30 days post treatment
时间窗: 30 days post treatment
A Major Adverse Event includes any of the following: bowel ischemia, myocardial infarction (heart attack), paraplegia, renal failure, respiratory failure, stroke, or blood loss greater than 1000 ml.
次要结局
- Subject Scores on Short Form-36 (SF-36) Quality of Life Questionnaire(baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years.)
- Number of Subjects Who Achieve Treatment Success(12 months)
研究者
Gustavo Oderich
Professor
The University of Texas Health Science Center, Houston