First Affiliated Hospital Xi'an Jiaotong University
Phase
Not applicable
Started
2024-01-11
Last updated
2024-07-12
Condition(s) studied
Type A Aortic DissectionComplication of Surgical ProcedureAortic Diseases
Investigational drug(s) / intervention(s)
Vascular Grafts Eversion and Built-in Technique(XJ-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.
Study 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
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
All-cause mortality — 12 months follow-up 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.
Trial sites (1)
Facility
City
Region
Status
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Shaanxi
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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