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

N/ARecruitingNCT06199401

First Affiliated Hospital Xi'an Jiaotong University680 enrolled

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

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)

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

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

Change of incidence of MACCE

MACCE includes all-cause of death, myocardial infarction, stroke and coronary revascularization. The data will be obtained during hospitalization, at the 3 months, 6 months, and 12 months follow-up, according to medical records and imaging findings of all patients.

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts