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临床试验/NCT05751200
NCT05751200
已完成
不适用

Safety and Efficacy of Aortic Root Reinforcement Combined With Vascular Grafts Eversion and built-in Procedure (XJ-procedure) in Patients With Acute Type A Aortic Dissection (ADVANCED-XJ ): an Investigator-initiated, Single-center, Cohort Study

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 183 人2023年3月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Type A Aortic Dissection
发起方
First Affiliated Hospital Xi'an Jiaotong University
入组人数
183
试验地点
1
主要终点
30-day mortality
状态
已完成
最后更新
2年前

概览

简要总结

This is a retrospective study based on the data available in our hospital database for ATAAD patients from January 2020 to December 2021. These patients were divided into two groups according to the surgical procedures of aortic root. This study compared baseline data, perioperative and short-term follow-up results between the two groups to evaluate the efficacy and safety of XJ-procedure in ATAAD.

详细描述

Acute type A aortic dissection (ATAAD) is a life-threatening disease with high mortality. Surgery remains the gold standard for the treatment of ATAAD. In recent years, ATAAD is still a persistent challenge for cardiovascular surgeons. This is a retrospective study based on the data available in our hospital database for ATAAD patients undergoing total aortic arch replacement with elephant trunk stent under cryogenic stop circulation from January 2020 to December 2021. These patients were divided into two groups according to the surgical procedures of aortic root: continuous aortic root suture group (CARS group); "aortic root reinforcement combined with vascular grafts eversion and built-in", which was created by our group and to be named as XJ-procedure (XJ-procedure group, XJ is an acronym for Xi'an Jiaotong University). The main outcome was defined as 30-day mortality. Secondary outcomes included the postoperative bleeding necessitating re-operation and the incidence of anastomotic pseudoaneurysm, residual aortic root dissection and severe aortic regurgitation before discharge and at 3 and 6 months after the operation. This study compared baseline data, perioperative and short-term follow-up results between the two groups to evaluate the efficacy and safety of XJ-procedure in ATAAD.

注册库
clinicaltrials.gov
开始日期
2023年3月1日
结束日期
2023年3月2日
最后更新
2年前
研究类型
Observational
性别
All

研究者

入排标准

入选标准

  • Diagnosed with ATAAD by computed tomography angiography (CTA) from January 2020 to December 2021 in the First Affiliated Hospital of Xi'an Jiaotong University
  • Mild to moderate aortic root involvement
  • Aortic arch involvement undergoing Sun's procedure

排除标准

  • Patients with severe aortic root involvement (root diameter \>45 mm, root tear, severe disruption of aortic root, concomitant valve disease)
  • The Bentall, Wheat or David procedure performed
  • Recurrent ATAAD
  • Preoperative severe brain complications (cerebral infarction, cerebral hemorrhage, coma, etc.)
  • Mal-perfusion of abdominal organs or lower extremities \>12 h
  • Incomplete clinical data.

结局指标

主要结局

30-day mortality

时间窗: Within 30 days after the surgery

Patients died within 30 days after the surgery. Data were obtained from the medical records.

次要结局

  • The postoperative bleeding necessitating re-operation(About 2 weeks after the surgery.)
  • Change in the incidence of anastomotic pseudoaneurysm(About 2 weeks after surgery, 3-month and 6-month follow-up.)
  • Change in the incidence of residual aortic root dissection(About 2 weeks after surgery, 3-month and 6-month follow-up.)
  • Change in the incidence of severe aortic regurgitation(About 2 weeks after surgery, 3-month and 6-month follow-up.)

研究点 (1)

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