Safety and Efficacy of XJ-Procedure in Patients With Acute Type A Aortic Dissection Surgery (ADVANCED-XJ-Ⅱ): A National, Multi-center, Open-label, Randomized, Controlled, Blinded-end Point Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 680
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
This is a national, multicenter, open-label, randomized, controlled, endpoint-blinded clinical trial of patients diagnosed with ATAAD and undergoing "Sun's procedure" coordinated by the First Affiliated Hospital of Xi'an Jiaotong University, China. Per the protocol, "Sun's procedure" combined with "XJ-Procedure" in the anastomosis of the aortic root and Sun's procedure combined with regular suturing methods of the aortic root will be compared.
详细描述
In this study, the investigators will prospectively enroll patients diagnosed with ATAAD and undergo "Sun's procedure" from November 2024 to November 2027 in several centers, including the First Affiliated Hospital of Xi'an Jiaotong University, and will randomly divide them into XJ-procedure group and control group. "The patients in the XJ-procedure group will undergo "Sun's procedure", in which the anastomosis of the aortic root will be performed with the XJ-procedure. The patients in the control group will also undergo "Sun's procedure", in which the anastomosis of the aortic root will be performed with each center. The primary outcome event is all-cause mortality within 12 months after surgery. Secondary outcome events are (1) incidence of residual aortic root entrapment (during hospitalization, follow-up 3 months, 6 months, 12 months) (2) rate of secondary surgery for hemostasis due to root hemorrhage (during hospitalization) (3) incidence of anastomotic pseudoaneurysm (during hospitalization, follow-up 3 months, 6 months, 12 months) (4) rate of severe regurgitation of residual aortic valves (during hospitalization, follow-up 3 months, 6 months, 12 months) (5) Incidence of major adverse cardiovascular and cerebrovascular events (MACCE) (during hospitalization, follow-up 3 months, 6 months, 12 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years;
- •Patients with ATAAD attending the relevant department who have been assessed by a clinician as needing "Sun's procedure".
排除标准
- •Severe aortic root involvement (root diameter >45 mm, root tear, severe destruction of the aortic root, combined valve disease);
- •Combined coronary artery disease requiring concomitant coronary revascularization;
- •Prior aortic or cardiac surgery;
- •Preoperative severe malperfusion syndromes such as: severe cerebral complications (acute cerebral infarction, cerebral hemorrhage, coma, etc.); malperfusion of abdominal organs or lower extremities >12 h;
- •Preoperative combination of severe single or multiple organ failure;
- •Pregnant women;
- •Refused to sign the informed consent form and refused to participate in this study.
结局指标
主要结局
All-cause mortality
时间窗: 12 months follow-up
This outcome is a time-to-event variable and its data will be obtained at 12 months follow-up, according to the medical records or phone calls of all patients.
次要结局
- Change of incidence of second surgery for hemostasis due to aortic root hemorrhage(About 20 days (during hospitalization))
- Change of incidence of severe residual aortic valve regurgitation(About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up)
- Change of incidence of MACCE(About 20 days (during hospitalization), at the 3 months,6 months, and 12 months follow-up)
- Change of incidence of residual aortic root dissection(About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up)
- Change of incidence of anastomotic pseudoaneurysms during hospitalization(About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up)