DediCated MuLtibranchEd DacrOn Graft for OPen RepAir of ThoRacoabdominal Aneurysms - CLEOPATRA Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- number of participants who obtain technical success
研究概览
简要总结
The objective of the study is the evaluation of the technical success and clinical outcomes of the surgical treatment of thoraco-abdominal aortic aneurysms treated by Jotec "TAAA spinal loop graft" "custom made "CE equivalent" branched prosthesis, compared with the patient cohort already treated with standard and / or bench-top prostheses Gelweave ™ Coselli Thoracoabdominal Grafts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •patients aged ≥ 18 years;
- •patients candidates for surgical treatment of thoraco-abdominal aorta of the II and III type sec. Crawford using "TAAA spinal loop graft" "custom made CE equivalent" prosthesis
排除标准
- •patients aged ≤ 18 years
结局指标
主要结局
number of participants who obtain technical success
时间窗: 12 month
number of surviving participants
incidence of thrombosis of the prosthetic branches, visceral arteries and replanted intercostal arteries
时间窗: 12 month
freedom from thrombosis of the prosthetic branches,visceral arteries and replanted intercostal arteries
incidence of aneurysmal dilatation of visceral and replanted intercostal arteries
时间窗: 12 month
freedom from surgical / endovascular reoperation for aneurysmal dilatation of visceral and replanted intercostal arteries
次要结局
未报告次要终点
研究者
Bertoglio Luca
Principal Investigator
IRCCS San Raffaele