The Aorta Arch Stent Graft System Combined With the Endovascular Needle System in Situ Fenestration Technology in the Treatment of Aortic Dissection Involving the Aortic Arch
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Primary safety end point of the Aorta Arch Stent Graft System: no Major Adverse events（MAE） occurrence within 30 days after surgery
研究概览
简要总结
A prospective, multi-center, single-group target value method to evaluate the safety and effectiveness of the Aorta Arch Stent Graft System combined with the Endovascular Needle System in situ fenestration technology in the treatment of aortic dissection involving the aortic arch
详细描述
- Clinical trials using prospective, multi-center, single-group target value design;
- 120 subjects with aortic dissection requiring partial arch reconstruction will be enrolled in more than 30 centers in China, and they will meet the test enrollment requirements.
- CTA examination was performed at baseline, 30 days, 6 months, 12 months, 36 months, and 60 months after surgery to determine the pathological status and the status of postoperative aortic and branch revascularization
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Primary safety end point of the Aorta Arch Stent Graft System: no Major Adverse events（MAE） occurrence within 30 days after surgery
时间窗: Within 30 days after procedure
MAE was defined as death related to aortic dissection, ischemic stroke, and paraplegia within 30 days after surgery
Primary endpoint of the Endovascular Needle System: Immediate surgical success rate of the Endovascular Needle System
时间窗: intraoperative
Intraoperative DSA, the membrane was successfully broken in situ with the membrane rupture system, and the membrane rupture system was successfully withdrawn
Primary efficacy endpoint of the Aorta Arch Stent Graft System: treatment success at 12 months after surgery
时间窗: 12 months after procedure
On the basis of successful surgery, the main and branch stents were unobstructed 12 months after surgery, with no internal leakage requiring intervention, no stent displacement (displacement ≤10mm), no new device-related rupture, and no device-induced aortic arch re-operation
次要结局
未报告次要终点