Safety and Efficacy of XJ-Procedure in Patients With Acute Type A Aortic Dissection Surgery
- Conditions
- Complication of Surgical ProcedureType A Aortic DissectionAortic Diseases
- Interventions
- Procedure: Vascular Grafts Eversion and Built-in Technique(XJ-Procedure)
- Registration Number
- NCT06199401
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 680
- Age 18-70 years;
- Patients with ATAAD attending the relevant department who have been assessed by a clinician as needing "Sun's procedure".
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description XJ-Procedure Group Vascular Grafts Eversion and Built-in Technique(XJ-Procedure) 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.
- Primary Outcome Measures
Name Time Method All-cause mortality 12 months follow-up This outcome is a time-to-event variable and its data will be obtained at 12 months follow-up, according to the medical records or phone calls of all patients.
- Secondary Outcome Measures
Name Time Method Change of incidence of second surgery for hemostasis due to aortic root hemorrhage About 20 days (during hospitalization) The data will be obtained during hospitalization, according to medical records of all patients.
Change of incidence of severe residual aortic valve regurgitation About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up The data will be obtained during hospitalization, at the 3 months, 6 months, and 12 months follow-up, according to the echocardiography results of all patients.
Change of incidence of MACCE About 20 days (during hospitalization), at the 3 months,6 months, and 12 months follow-up MACCE includes all-cause of death, myocardial infarction, stroke and coronary revascularization. The data will be obtained during hospitalization, at the 3 months, 6 months, and 12 months follow-up, according to medical records and imaging findings of all patients.
Change of incidence of residual aortic root dissection About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up The data will be obtained during hospitalization, at the 3 months, 6 months, and 12 months follow-up, according to CTA and echocardiography results of all patients.
Change of incidence of anastomotic pseudoaneurysms during hospitalization About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up The data will be obtained during hospitalization at the 3 months, 6 months, and 12 months follow-up, according to CTA and echocardiography results of all patients.
Trial Locations
- Locations (1)
First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China