Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Successful implantation of TAAA branched stent-graft.
研究概览
简要总结
This is a study to assess the safety and effectiveness of endovascular treatment of thoracoabdominal (TAAA) and paravisceral abdominal (PVAAA) aortic aneurysms. The investigational operation involves placing a stent-graft over the aortic aneurysm.
详细描述
A TAAA or PVAAA is an abnormal enlargement of the aorta, the main artery in the chest and abdomen. The standard operation for TAAA of PVAAA is performed through a long incision extending down the side of the chest and the front of the abdomen. In the standard operation, the weak area of the aorta is replaced with a fabric sleeve (graft). The investigational operation is done making small incisions in both groins and the right arm and placing a graft in the aorta through tubes that are inserted through the femoral and brachial arteries, than fastening it in position with metal springs(stents). The combination of a stent and a graft is known as a stent-graft. Compared with standard operation, the potential advantages of endovascular TAAA/PVAAA repair include less pain, less disturbance of intestinal function, a lower risk of pulmonary or cardiac complications and shorter hospital stay. The main disadvantage of endovascular TAAA/PVAAA is an unknown success rate.
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
- •Aortic aneurysms:
- •greater than or equal to 6 cm in diameter in men,
- •greater than or equal to 5.5 cm in diameter in women,
- •and/or larger than 5 cm in diameter and enlarging at a rate of more than 5 mm/year,
- •and/or iliac aneurysms larger than 4 cm in diameter.
- •Anticipated mortality comparable to published rates with conventional surgical treatment.
- •Life expectancy more than 2 years.
- •Ability to give informed consent.
- •Willingness to comply with follow-up schedule.
- •Suitable arterial anatomy for endovascular repair.
排除标准
- •Free rupture of the aneurysm.
- •Known allergy to Nitinol, stainless steel, or polyester.
- •Unwillingness or inability to comply with the follow up schedule.
- •Serious systemic or groin infection.
- •Uncorrectable coagulopathy.
研究组 & 干预措施
Interventional
Endovascular Branched Stent-Graft: The investigational operation is done making small incisions in both groins and the right arm and placing a graft in the aorta through tubes that are inserted through the femoral and brachial arteries, than fastening it in position with metal springs(stents).
干预措施: Endovascular Branched Stent-Graft (Device)
结局指标
主要结局
Successful implantation of TAAA branched stent-graft.
时间窗: 1 month
次要结局
- Long term success of TAAA branched stent-graft treatment.(5 years)
研究者
Warren J. Gasper, MD
Associate Professor, Surgery
University of California, San Francisco