Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06199401
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2023-12-18
Brief Title:
Safety and Efficacy of XJ-Procedure in Patients With Acute Type A Aortic Dissection Surgery
Sponsor:
First Affiliated Hospital Xian Jiaotong University
Organization:
First Affiliated Hospital Xian Jiaotong University
Study Overview
Official Title:
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
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADVANCED-XJ-Ⅱ
Brief Summary:
This is a national multicenter open-label randomized controlled endpoint-blinded clinical trial of patients diagnosed with ATAAD and undergoing Suns procedure coordinated by the First Affiliated Hospital of Xian Jiaotong University China Per the protocol Suns procedure combined with XJ-Procedure in the anastomosis of the aortic root and Suns procedure combined with regular suturing methods of the aortic root will be compared
Detailed Description:
In this study the investigators will prospectively enroll patients diagnosed with ATAAD and undergo Suns procedure from November 2024 to November 2027 in several centers including the First Affiliated Hospital of Xian Jiaotong University and will randomly divide them into XJ-procedure group and control group The patients in the XJ-procedure group will undergo Suns procedure in which the anastomosis of the aortic root will be performed with the XJ-procedure The patients in the control group will also undergo Suns procedure in which the anastomosis of the aortic root will be performed with each center The primary outcome event is all-cause mortality within 12 months after surgery Secondary outcome events are 1 incidence of residual aortic root entrapment during hospitalization follow-up 3 months 6 months 12 months 2 rate of secondary surgery for hemostasis due to root hemorrhage during hospitalization 3 incidence of anastomotic pseudoaneurysm during hospitalization follow-up 3 months 6 months 12 months 4 rate of severe regurgitation of residual aortic valves during hospitalization follow-up 3 months 6 months 12 months 5 Incidence of major adverse cardiovascular and cerebrovascular events MACCE during hospitalization follow-up 3 months 6 months 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None