Complication of Surgical Procedure Clinical Trial
— ADVANCED-XJ-?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
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.
Status | Not yet recruiting |
Enrollment | 680 |
Est. completion date | December 1, 2027 |
Est. primary completion date | March 1, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital Xi'an Jiaotong University | Qinghai People's Hospital, Second Affiliated Hospital of Nanchang University, Zhejiang Provincial People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 12 months follow-up | |
Secondary | 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. | About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up | |
Secondary | 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. | About 20 days (during hospitalization) | |
Secondary | 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. | About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up | |
Secondary | 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. | About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up | |
Secondary | Change of incidence of MACCE | 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. | About 20 days (during hospitalization), at the 3 months,6 months, and 12 months follow-up |
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