跳至主要内容
临床试验/NCT04544579
NCT04544579Unknown不适用

Endovascular Graft Anchoring Different Regions of Ascending Aorta in the Treatment of Ascending Aortic Dissection: a Prospective, Controlled and Multicenter Study

Chinese Medical Association0 个研究点目标入组 200 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
主要终点
success of operation

研究概览

简要总结

Aortic dissection is a deadly and dangerous disease. About 28% of patients with ascending aortic dissection can't tolerate open surgical trauma caused by thoracotomy and cardiopulmonary bypass, and the prognosis is poor. Minimally invasive endovascular treatment has been applied in the treatment of descending aortic dissection. However, due to the special anatomical structure and high speed /pressure blood flow, the treatment of ascending aorta dissection has become an international difficulty.

详细描述

This study was designed combination of retrospective and prospective methods, and focused on distal false lumen Aneurysmal Expansion of Aortic Dissection (DAEAD) . To formulate clinical data for the risk assessment of DAEAD, and best intracavitary treatment or long-term efficacy evaluation, we combined the results of genetic testing, evaluating the missense mutation, computer simulation of blood flow dynamics analysis, and clinical imaging analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aortic dissection diagnosed by CTA;
  • With indications for endovascular treatment
  • The luminal graft anchor is required to be located in the ascending aorta.

排除标准

  • Import difficult, such as external iliac artery diameter is less than 6 mm bilateral iliac, artery stenosis distortions;
  • Patients with severe comorbidities, such as severe myocardial insufficient blood supply, heart failure, arrhythmia, severe renal dysfunction, and severe blood coagulation dysfunction;
  • Patients with malignant tumor, or other serious illness, life expectancy of less than 1 year;
  • Puncture local infection and high fever;⑤ within 1 month of the large area;
  • Contrast media in patients with cerebrovascular accident or digestive tract hemorrhage patients with allergies;
  • Aortic ulcer or aortic wall hematoma and other atypical dissection.

结局指标

主要结局

success of operation

时间窗: before December 2022

The operation was completed successfully without complications.

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Principal Investigator
主要研究者

Zaiping Jing

Professor

Chinese Medical Association

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