Safety and Efficacy of XJ-Procedure in Patients With Acute Type A Aortic Dissection Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vascular Grafts Eversion and Built-in Technique(XJ-Procedure).
- Who it may be relevant to
- Registry conditions: Type A Aortic Dissection, Complication of Surgical Procedure, Aortic Diseases. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Detailed description
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).
Interventions
- Procedure Vascular Grafts Eversion and Built-in Technique(XJ-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.
Primary outcome measures
- All-cause mortality [Time frame: 12 months follow-up]
Secondary outcome measures (5)
- Change of incidence of residual aortic root dissection [Time frame: About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up]
- Change of incidence of second surgery for hemostasis due to aortic root hemorrhage [Time frame: About 20 days (during hospitalization)]
- Change of incidence of anastomotic pseudoaneurysms during hospitalization [Time frame: 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 [Time frame: About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up]
- Change of incidence of MACCE [Time frame: About 20 days (during hospitalization), at the 3 months,6 months, and 12 months follow-up]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- First Affiliated Hospital of Xi'an Jiaotong University — Xi'an
Identifiers
NCT: NCT06199401 · XJTU1AF2023LSYY-006-1