Safety and Efficacy of XJ-Procedure in Patients With Acute Type A Aortic Dissection Surgery (ADVANCED-XJ-Ⅱ): A National, Multi-center, Open-label, Randomized, Controlled, Blinded-end Point Trial
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a national, multicenter, open-label, randomized, controlled, endpoint-blinded clinical trial of patients diagnosed with ATAAD and undergoing Sun's procedure coordinated by the First Affiliated Hospital of Xi'an Jiaotong University, China. Per the protocol, Sun's procedure combined with XJ-Procedure in the anastomosis of the aortic root and Sun's procedure combined with regular suturing methods of the aortic root will be compared.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Age 18-70 years;
• Patients with ATAAD attending the relevant department who have been assessed by a clinician as needing Sun's procedure.
Locations
Other Locations
China
First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
Contact Information
Primary
Yang Yan
yangyan3@xjtu.edu.cn
+86.29.85323869
Backup
Guoliang Li
liguoliang_med@163.com
+86.29.85323869
Time Frame
Start Date: 2024-01-11
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 680
Treatments
Experimental: XJ-Procedure Group
In the XJ-Procedure Group, Patients will be performed the standard Sun's procedure after general anesthesia, in which the end-to-end anastomosis between the artificial vessel and the aortic root is performed using the Vascular Grafts Eversion and Built-in Technique during the aortic root suture.
No_intervention: Control Group
In the Control Group, Patients will be performed the standard Sun's procedure which involves aortic root anastomosis using the regular technique at each cardiovascular surgery center.
Related Therapeutic Areas
Sponsors
Collaborators: Qinghai People's Hospital, Second Affiliated Hospital of Nanchang University, Zhejiang Provincial People's Hospital
Leads: First Affiliated Hospital Xi'an Jiaotong University