NCT07143071进行中（未招募）不适用
Endovascular Treatment for Acute High-risk Type B Aortic Dissection in Acute VS Subacute Phase: a Prospective, Multicenter, Non-inferior, Parallel Controlled Trial
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 4,068 人开始时间: 2025年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,068
- 试验地点
- 1
- 主要终点
- 30-day all-cause mortality rate
研究概览
简要总结
This is a prospective, multicenter, non-inferior, parallel-controlled observational study. This study aims to compare clinical outcomes of endovascular treatment for acute high-risk type B aortic dissection in the acute phase versus the subacute phase. No interventions will be imposed on the patients' standard treatment. Patients with acute high-risk type B aortic dissection will be grouped based on the actual timing of their treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Acute (2-14 days) high-risk type B aortic dissection.
- •Completion of thoracoabdominal aortic CTA before enrollment.
- •Ability to understand the study objectives and voluntarily participate, with signed informed consent from the patient or their legal representative.
- •Willingness and ability to comply with follow-up visits and study protocols.
排除标准
- •Acute complicated type B aortic dissection.
- •Traumatic dissection or penetrating aortic ulcer.
- •Connective tissue diseases (e.g., Marfan syndrome, Loeys-Dietz syndrome, Ehlers-Danlos syndrome).
- •Pregnancy, women of childbearing potential, or breastfeeding.
- •Uncontrolled active infection or active vasculitis.
- •Unsuitable access vessels or infection at the access site.
- •Endovascular repair requiring ≥2 branch reconstructions.
- •Prior aortic surgery (open or endovascular).
- •Life expectancy <2 years.
- •Myocardial infarction or cerebrovascular accident within 4 weeks before enrollment.
- •Severe gastrointestinal bleeding, major surgery, myocardial infarction, or uncorrected coagulation dysfunction within 6 weeks before enrollment.
- •Other conditions deemed by the investigator to compromise the patient's medical interests or unlikely adherence to the study protocol.
结局指标
主要结局
30-day all-cause mortality rate
时间窗: 30 days following the operation
paraplegia, stroke, new entry tear, renal/liver dysfunction, type I/II/R endoleak
30-day complication rate
时间窗: 30 days following the operation
access site complications
次要结局
- 5-year complication rate(5 years following the operation)
- Adverse events(12 months following the operation)
- aortic remodeling(12 months following the operation)
- 5-year all-cause mortality rate(5 years following the operation)
研究者
Zhihui Dong
Professor
Shanghai Zhongshan Hospital
研究点 (1)
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