Clinical trial NCT06199401: Safety and Efficacy of XJ-Procedure in Patients With Acute Type A Aortic Dissection Surgery
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type A Aortic Dissection
Complication of Surgical Procedure
Aortic Diseases
Keywords: Type A Aortic Dissection
Aortic Root Reinforcement
Cardiovascular Surgery
Postoperative Complication
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Zhejiang Provincial People's Hospital
name: Second Affiliated Hospital of Nanchang University
name: Qinghai People's Hospital
First posted: 2024-01-10
Enrollment: 680
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: In this study, the investigators will prospectively enroll patients diagnosed with ATAAD and undergo "Sun's procedure" from November 2024 to November 2027 in several centers, including the First Affiliated Hospital of Xi'an Jiaotong University, and will randomly divide them into XJ-procedure group and control group. "The patients in the XJ-procedure group will undergo "Sun's 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 "Sun's 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).

Eligibility criteria: Inclusion Criteria:

* Age 18-70 years;
* Patients with ATAAD attending the relevant department who have been assessed by a clinician as needing "Sun's procedure".

Exclusion Criteria:

* Severe aortic root involvement (root diameter \>45 mm, root tear, severe destruction of the aortic root, combined valve disease);
* Combined coronary artery disease requiring concomitant coronary revascularization;
* Prior aortic or cardiac surgery;
* Preoperative severe malperfusion syndromes such as: severe cerebral complications (acute cerebral infarction, cerebral hemorrhage, coma, etc.); malperfusion of abdominal organs or lower extremities \>12 h;
* Preoperative combination of severe single or multiple organ failure;
* Pregnant women;
* Refused to sign the informed consent form and refused to participate in this study.

Primary outcomes:
measure: All-cause mortality
timeFrame: 12 months follow-up
Secondary outcomes:
measure: Change of incidence of residual aortic root dissection
timeFrame: About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up
measure: Change of incidence of second surgery for hemostasis due to aortic root hemorrhage
timeFrame: About 20 days (during hospitalization)
measure: Change of incidence of anastomotic pseudoaneurysms during hospitalization
timeFrame: About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up
measure: Change of incidence of severe residual aortic valve regurgitation
timeFrame: About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up
measure: Change of incidence of MACCE
timeFrame: About 20 days (during hospitalization), at the 3 months,6 months, and 12 months follow-up
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yang Yan
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Guoliang Li
role: PRINCIPAL_INVESTIGATOR
References: