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| Name | Class |
|---|---|
| Zhejiang Provincial People's Hospital | OTHER |
| Second Affiliated Hospital of Nanchang University | OTHER |
| Qinghai People's Hospital | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XJ-Procedure Group | Experimental | 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. |
|
| Control Group | No Intervention | In the Control Group, Patients will be performed the standard "Sun's procedure" which involves aortic root anastomosis using the regular technique at each cardiovascular surgery center. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vascular Grafts Eversion and Built-in Technique(XJ-Procedure) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Yan | Contact | +86.29.85323869 | yangyan3@xjtu.edu.cn | |
| Guoliang Li | Contact | +86.29.85323869 | liguoliang_med@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yang Yan | First Affiliated Hospital Xi'an Jiaotong University | Principal Investigator |
| Guoliang Li | First Affiliated Hospital Xi'an Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
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| 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) |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D001018 | Aortic Diseases |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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