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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFirst Affiliated Hospital Xi'an Jiaotong University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-70 years;

Patients with ATAAD attending the relevant department who have been assessed by a clinician as needing "Sun's procedure".

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vascular Grafts Eversion and Built-in Technique(XJ-Procedure)

    Procedure/Surgery

    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.

Treatment groups

680 Participants
are divided into 2 treatment groups
Group A: XJ-Procedure GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

All-cause mortality

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.

Time frame
12 months follow-up

Secondary outcomes

1

Change of incidence of residual aortic root dissection

The data will be obtained during hospitalization, at the 3 months, 6 months, and 12 months follow-up, according to CTA and echocardiography results of all patients.

Time frame
About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up
2

Change of incidence of second surgery for hemostasis due to aortic root hemorrhage

The data will be obtained during hospitalization, according to medical records of all patients.

Time frame
About 20 days (during hospitalization)
3

Change of incidence of anastomotic pseudoaneurysms during hospitalization

The data will be obtained during hospitalization at the 3 months, 6 months, and 12 months follow-up, according to CTA and echocardiography results of all patients.

Time frame
About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up
4

Change of incidence of severe residual aortic valve regurgitation

The data will be obtained during hospitalization, at the 3 months, 6 months, and 12 months follow-up, according to the echocardiography results of all patients.

Time frame
About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up

Other outcomes

Sponsors and contacts

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First Affiliated Hospital Xi'an Jiaotong University

Lead sponsor

Zhejiang Provincial People's Hospital

Collaborator

Second Affiliated Hospital of Nanchang University

Collaborator

Qinghai People's Hospital

Collaborator