About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age 18-70 years;
Patients with ATAAD attending the relevant department who have been assessed by a clinician as needing "Sun's procedure".
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Vascular Grafts Eversion and Built-in Technique(XJ-Procedure)
Procedure/SurgeryA 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.
Treatment groups
Trial outcomes
Primary outcomes
All-cause mortality
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 outcomes
Change of incidence of residual aortic root dissection
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
The data will be obtained during hospitalization, according to medical records of all patients.
Change of incidence of anastomotic pseudoaneurysms during hospitalization
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
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.
Sponsors and contacts
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First Affiliated Hospital Xi'an Jiaotong University
Lead sponsor
Zhejiang Provincial People's Hospital
Collaborator
Second Affiliated Hospital of Nanchang University
Collaborator
Qinghai People's Hospital
Collaborator