Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 401
- 试验地点
- 2
- 主要终点
- Freedom From Aneurysm Rupture
研究概览
简要总结
The purpose of this study is to assess the role of abdominal aneurysm and iliac aneurysm exclusion using an endovascular prosthesis.
详细描述
This study is a prospective, non-randomized evaluation of endovascular aneurysm repair in high-risk patients. The purpose of this study is to determine whether this endovascular prosthesis is safe and effective for the intended use of treating AAA/iliac aneurysm in patients who are at high risk for standard aneurysm surgical repair. Up to 400 patients will be enrolled at the Cleveland clinic Foundation. Baseline procedures may include angiogram, intravascular ultrasound, CT scan, physical exam, blood work and ankle-brachial index. The endovascular prosthesis is placed in the operating room under regional or general anesthesia and the procedure length is approximately 2-3 hours. Follow up evaluations will be done at 1 month, 6 months (if clinically necessary), 12 months and yearly, and may include a physical exam, CT scan, KUB, ultrasound, blood work, and an ankle-brachial index.
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
- •The aneurysm is >/= 5 cm or larger, or with a high risk of rupture due to its shape, history of growth, symptoms, or the presence of a large (>2 cm) iliac aneurysm
- •Anticipated mortality greater than 10 percent with conventional surgery
- •Life expectancy greater than 2 years
- •Suitable arterial anatomy
- •Absence of systemic disease or allergy that precludes an endovascular repair
- •Capable of giving informed consent and willingness to comply with the follow-up schedule
排除标准
- •Pregnancy
- •History of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately
- •Allergy to stainless steel or polyester
- •Unwilling to comply with the follow-up schedule
- •Serious or systemic groin infection
- •Coagulopathy, other than coumadin therapy
- •Inability to give informed consent
研究组 & 干预措施
Endovascular Aneurysm Repair
Investigational stent-graft implant to exclude aneurysm
干预措施: Endovascular Aneurysm Repair (Device)
结局指标
主要结局
Freedom From Aneurysm Rupture
时间窗: 2 years
Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan
次要结局
未报告次要终点
研究者
Federico Ezequiel Parodi
Staff
The Cleveland Clinic
