A Real-World Study on Distal Aortic Remodeling for Stanford Type B Aortic Dissection With Fabulous Thoracic Aortic Stent System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Changes of cross-sectional area
研究概览
简要总结
To evaluate aortic remodeling of Fabulous thoracic aortic stent system in the treatment of acute and subacute Stanford type B aortic dissection (the changes of aortic diameter, cross-sectional area,and volume of true lumen, false lumen and total aorta in different aoritc levels, and false lumen thrombosis in different aoritc levels), and splanchnic artery perfusion.
详细描述
Fabulous Thoracic Aortic Stent System is specially designed for aortic dissection based on PETTICOAT technique.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •≥18 years old, regardless of gender;
- •Fabulous thoracic aortic stent System is suitable for the treatment of acute or subacute Stanford type B dissection, and the lesions meet one of the following criteria:
- •It is necessary to treat distal lesions due to the presence of distal tears;
- •The dissection involved a wide range, and there was collapse of the distal true cavity;
- •Dissection combined with poor perfusion of distal branch vessels.
- •With appropriate arterial access and suitable for endovascular aortic repair;
- •Subjects could understand the purpose of the trial, volunteered to participate in the study, signed the informed consent form by themselves or their legal representatives, and were willing to complete the follow-up as required by the protocol.
排除标准
- •Patients have participated in clinical trials of other drugs or medical devices related to target lesion treatment or have participated in clinical trials of other drugs or medical devices and have not reached the primary endpoint;
- •Patients were unable or unwilling to participate in the study;
- •Patients were judged by the investigator to be ineligible for participation in the trial.
结局指标
主要结局
Changes of cross-sectional area
时间窗: 3 months, 6 months,12 months after operation
The changes of true lumen, false lumen and total aortic cross-sectional area before and after surgery in the level of pulmonary artery bifurcation/left atrial (L1), the distal end of covered stent (L2), superior mesenteric artery (L3) and abdominal aortic bifurcation (L4) were recorded.
Volumetric change
时间窗: 3 months, 6 months,12 months after operation
The volumes of the true lumen and false lumen of the aorta before and after surgery were measured from the covered stent placement segment, the proximal end of the bare stent to the level of celiac trunk, from the level of celiac trunk to the level of low kidney, and from the level of low kidney to the abdominal aorta bifurcation.
Change of diameter
时间窗: 3 months, 6 months,12 months after operation
The changes of true lumen, false lumen and total aortic diameter before and after surgery in the level of pulmonary artery bifurcation/left atrial (L1), the distal end of covered stent (L2), superior mesenteric artery (L3) and abdominal aortic bifurcation (L4) were recorded.
次要结局
- Incidence of distal new entry(3 months, 6 months,12 months after operation)
- Tortuosity of the descending thoracic aorta(3 months, 6 months,12 months after operation)
- Incidence of type I and III endoleak(Immediate during surgery,3 months, 6 months,12 months after operation)
- Incidence of severe adverse events(3 months, 6 months,12 months after operation)
- Immediate technical success(Immediate during surgery)
- Major adverse events occurring within 30 days after surgery(within 30 days after operation)
- Splanchnic arteries perfusion(3 months, 6 months,12 months after operation)