Safety and Efficacy of XJ-Procedure in Patients With Acute Type A Aortic Dissection Surger
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
| Condition(s) | Type A Aortic Dissection, Complication of Surgical Procedure, Aortic Diseases |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 participa |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | First Affiliated Hospital Xi'an Jiaotong University |
| Locations | Xi'an, Shaanxi, China |
| Start date | 2024-01-11 |
| NCT ID | NCT06199401 |
| Official listing | https://clinicaltrials.gov/study/NCT06199401 |