A Physician-initiated, National, Multicentre, Ambispective, Observational Registry of Patients Undergoing Branched Endovascular Aortic Procedures With a Total Transfemoral Approach. (TORCH2 Registry)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- technical success
研究概览
简要总结
The purpose of the registry is to evaluate the peri-operative, short-, and mid- outcomes of endovascular treatment of thoracoabdominal aneurysms with multibranched endografts via total transfemoral approach for visceral vessels cannulation using steerable sheaths
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •patient adult ( ≥18 years) of either sex,
- •patients who underwent a complex aortic procedure requiring a branched endograft via total transfemoral approach in the centers involved in the TORCH2 Registry
排除标准
- •patients who did not receive treatment via total transfemoral approach,
- •patient with bleeding diathesis or coagulopathy,
- •patients with active systemic or cutaneous infection or inflammation,
- •patients who are pregnant or lactating,
- •patient younger than 18 years of age.
- •Absence of at least one imaging follow-up within the first post-operative year
结局指标
主要结局
technical success
时间窗: 30 days
successful bridging stent graft deployment of all vessels, with aneurysm exclusion, without any signs of type I or type III endoleak, and with no evidence of stenosis/occlusion and mating stent dislocation/kinking at intraoperative completion angiography.
branch instability
时间窗: 30 days
freedom from any branch related complications and/or required reinterventions
clinical success
时间窗: 30 days
absence of death, type I/III endoleak, graft infection/thrombosis, aneurysm expansion and/or rupture, conversion to open repair, or new treatment-related thoracoabdominal pathologies
次要结局
未报告次要终点