Aortic dissection
Conditions
Interventions
Test group:This experiment adopts a central randomization method based on computer systems. When the patient voluntarily signs the informed consent form and meets the screening criteria of the trial,
Control group:This experiment adopts a central randomization method based on computer systems. When the patient voluntarily signs the informed consent form and meets the screening criteria of the tria
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age >= 18 years old and <= 75 years old, gender not limited; 2) Diagnosed with Stanford type A or Stanford type B aortic dissection, subjects who are suitable for stent elephant trunk surgery treatment according to the researcher's judgment; 3) The subjects or their legal representatives are able to understand the purpose of the trial, have sufficient compliance with the clinical trial protocol, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Aortic dissection limited to the ascending aorta and/or aortic arch; 2) Stanford type B aortic dissection involving the abdominal aorta; 3) Subjects with vertebral artery variations; 4) Subjects with severe preoperative hypoperfusion in aortic dissection (such as coma or paraplegia caused by ischemia, progressive liver and kidney dysfunction, gastrointestinal necrosis, limb necrosis, etc.); 5) Subjects who have undergone open surgery on the cardiovascular and cerebrovascular system within 90 days prior to surgery; 6) Subjects with infectious aortic dissection; 7) Subjects with uncontrolled severe infections and related sepsis, shock, or multiple organ failure; 8) Subjects with active bleeding, coagulation disorders, or refusal to receive blood transfusions; 9) Subjects who cannot tolerate anesthesia and extracorporeal circulation; 10) Subjects known to be allergic to contrast agents and implant materials; 11) Subjects with an expected lifespan of less than 12 months (excluding diseases caused by aortic dissection); 12) Those who are currently participating in other clinical trials and have not yet completed the primary endpoint follow-up; 13) Pregnant and lactating women, as well as subjects who are willing to conceive during clinical trials; 14) The researchers believe that it is not suitable to participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival rate [12 months after surgery]; | — |
Secondary
| Measure | Time frame |
|---|---|
| Instrument success rate [intraoperative];Surgical success rate [intraoperative] ;Blood transfusion volume [intraoperative];Surgery time [intraoperative];Extracorporeal circulation time [intraoperative];Stop cycle time [intraoperative];Cerebral perfusion time [intraoperative];Cardiac block time [intraoperative] ; ICU time [before discharge] ; Hospitalization time [before discharge] ;Treatment success rate [6 months, 12 months after surgery] ;12 months false cavity closure rate; | — |
Countries
China
Contacts
Public ContactYang Yan
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed