Safety and Efficacy of XJ-Procedure in Patients With Acute Type A Aortic Dissection Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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)

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