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临床试验/NCT00583414
NCT00583414已完成不适用

Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 401 人开始时间: 1998年9月最近更新:
适应症
干预措施

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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Federico Ezequiel Parodi

Staff

The Cleveland Clinic

研究点 (2)

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