Safety and Efficacy of XJ-Procedure in Patients With Acute Type A Aortic Dissection Surgery
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
First Affiliated Hospital Xi'an Jiaotong University
680 participants
Jan 11, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- Age 18-70 years;
- Patients with ATAAD attending the relevant department who have been assessed by a clinician as needing "Sun's procedure".
Exclusion Criteria7
- 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.
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Interventions
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.
Locations(1)
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NCT06199401