Aortic Diseases, Complication of Surgical Procedure, Type A Aortic Dissection
Conditions
Keywords
Type A Aortic Dissection, Aortic Root Reinforcement, Cardiovascular Surgery, Postoperative Complication
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).
Interventions
PROCEDUREVascular Grafts Eversion and Built-in Technique(XJ-Procedure)
A 1.5-2cm wide bovine pericardial patch and graft ring will be placed inside and outside the aortic root and against the aortic wall, respectively, and continuously sutured near the commissure using 5-0 polypropylene. Then an eversion about 15mm of vascular graft will be intermittently sutured to full layers of aortic vascular with 2-0 pad polyester suture. Finally, the eversion and aortic wall will be continuously sutured together in one more turn.
Sponsors
Zhejiang Provincial People's Hospital
Second Affiliated Hospital of Nanchang University
Qinghai People's Hospital
First Affiliated Hospital Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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. |
Countries
China
Contacts
Primary ContactYang Yan
Backup ContactGuoliang Li
Outcome results
None listed