Effectiveness and Safety of a Type A Dissection Total Endovascular REconstruction System in Promoting Favorable Distal AOrtic ReModeling After Total Arch Replacement With Frozen Elephant Trunk for Type A Aortic Dissection: A Prospective, Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Change in False Lumen Volume of the Distal Aortic Dissection at 12 months
研究概览
简要总结
This is a prospective, multicenter, randomized controlled clinical study. A total of 198 eligible subjects will be enrolled and randomly assigned in a 1:1 ratio to either the Study Group or the Control Group. Subjects in the Study Group will receive surgical treatment using the study device (Type A Dissection Total Endovascular Reconstruction System) in addition to standard medical therapy following the Total Arch Replacement with Frozen Elephant Trunk. Subjects in the Control Group will continue standard medical therapy without surgical treatment using the study device following Total Arch Replacement with Frozen Elephant Trunk. Clinical follow-ups will be conducted at 30 days (±7 days), 6 months (±30 days), and 12 months (±30 days) post-enrollment to evaluate the effectiveness and safety of the study device.
After all subjects complete the 12-month (±30 days) follow-up, a statistical analysis will be performed and the results will be submitted for the study device registration application. Long-term follow-up will continue for 2-5 years post-enrollment.
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
- 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
- •Age ≥18 years, male or female.
- •Within 90 days of onset of Stanford Type A Aortic Dissection and 30 days post Total Arch Replacement with Frozen Elephant Trunk treatment (assessed via CTA at 30±7 days post open surgery):
- •Presence of any intimal tear in the residual dissection of the thoracic aorta and the false lumen is not completely thrombosed.
- •The intercostal arteries in the segment of the residual thoracic aortic dissection are primarily supplied by the false lumen (number of intercostal arteries supplied by false/mixed lumen > number supplied by true lumen; only intercostal arteries filled with contrast agent are considered).
- •False lumen volume in the thoracic aorta distal to the frozen elephant trunk stent graft is >50% of the total aortic lumen volume.
- •Voluntarily participate in this study and provide signed informed consent.
排除标准
- •Presence of a proximal anastomotic leak at the frozen elephant trunk site post open surgery.
- •No left subclavian artery revascularization during the open surgery.
- •Presence of severe endoleak, or residual dissection expansion ≥55mm, or distal stent graft-induced new entry.
- •History of myocardial infarction, or stroke (with clear symptoms/signs and culprit lesion), or bowel ischemia within 1 month prior to the procedure.
- •Previous history of descending thoracic or abdominal aortic surgery.
- •Lack of suitable vascular access.
- •Known allergy to components of the study device (e.g., Nitinol) or contrast agent.
- •Renal insufficiency (creatinine >2.5 times the upper limit of normal) or requiring long-term regular dialysis.
- •Severe liver dysfunction (Child-Pugh Class C).
- •Active bleeding, coagulation disorders, thrombocytopenia (platelet count <50×109/L), or refusal of blood transfusion.
- •Uncontrolled severe infection and associated sepsis, shock, or multiple organ failure.
- •Life expectancy less than 12 months (due to conditions other than aortic dissection).
- •Known or suspected connective tissue degenerative disease, or family history of aortic dissection.
- •Pregnant or lactating women.
- •Concurrent participation in other drug or medical device clinical studies.
- •Subjects deemed unsuitable for participating the study by the investigator.
研究组 & 干预措施
Study Group
Standard medical therapy (e.g., blood pressure and heart rate control) plus endovascular repair with Study device following the Total Arch Replacement with Frozen Elephant Trunk for Stanford Type A Aortic Dissection.
干预措施: surgical treatment (Device)
Study Group
Standard medical therapy (e.g., blood pressure and heart rate control) plus endovascular repair with Study device following the Total Arch Replacement with Frozen Elephant Trunk for Stanford Type A Aortic Dissection.
干预措施: Standard of Care (Investigator Choice) (Drug)
Control Group
Standard medical therapy (e.g., blood pressure and heart rate control) without endovascular repair with Study device following the Total Arch Replacement with Frozen Elephant Trunk for Stanford Type A Aortic Dissection.
干预措施: Standard of Care (Investigator Choice) (Drug)
结局指标
主要结局
Change in False Lumen Volume of the Distal Aortic Dissection at 12 months
时间窗: 12 months (±30 days) post-enrollment
Defined as the difference in the false lumen volume of the distal aortic dissection (distal to the frozen elephant trunk stent, including thrombosis portions) at baseline and 12 months (±30 days) post-enrollment among subjects in the Study group and Control group, respectively
The incidence of major adverse events (MAEs) within 30 days
时间窗: 30 days (±7 days) after enrollment
The percentage of subjects in the study or control group who experience any MAEs within 30 days (±7 days) after enrollment, relative to the total number of subjects in each group.
次要结局
- Procedure Success Rate (%) (Immediate post-procedure) (Study Group only)(Immediately post procedure)
- Treatment Success Rate (%) (12 months) (Study Group only)(12 months (±30 days) after enrollment)
- Change in True Lumen Volume of the Distal Aortic Dissection (at 30 days, 6, 12 months, 2-5 years)(30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment.)
- Change in False Lumen Volume of the Distal Aortic Dissection (at 30 days, 6 months, 2-5 years)(30 days (±7 days), 6 months (±30 days), and 2-5 years (±30 days) after enrollment)
- Change in Maximum Diameter of the Distal Aorta (True + False Lumen) (at 30 days, 6, 12 months, 2-5 years)(30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment)
- Thrombosis Status of the False Lumen in the Distal Aortic Dissection (at 30 days, 6, 12 months, 2-5 years)(30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment)
- Rate of Secondary Intervention Related to the Distal Aortic Dissection (at 30 days, 6, 12 months, 2-5 years)(30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment.)
- Survival Rate (6, 12 months, 2-5 years)(6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment)
- Incidence of MAE (6, 12 months, 2-5 years)(6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment)
- Incidence of Paraplegia/Spinal Cord Ischemia (at 30 days, 6, 12 months, 2-5 years)(30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment.)
- Incidence of Acute Kidney Injury (at 30 days, 6, 12 months, 2-5 years)(30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment.)
- Incidence of Stroke (at 30 days, 6, 12 months, 2-5 years)(30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment)
- Incidence of Stent Migration (at 30 days, 6, 12 months) (Study Group only)(30 days (±7 days), 6 months (±30 days), and 12 months (±30 days) after enrollment.)
- Incidence of AE/SAEs(Through study completion, an average of 5 year)
- Incidence of Device Deficiencies (Study Group only)(Through study completion, an average of 5 year)