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NCT Number: NCT06199401

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

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.

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Key information

Conditions

Type A Aortic Dissection Aortic Diseases Cardiovascular Diseases Complication of Surgical Procedure Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. All-cause mortality

    Time frame: 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.

Secondary outcomes

  1. 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

    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.

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

    Time frame: About 20 days (during hospitalization)

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

  3. 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

    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.

  4. 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

    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.

  5. Change of incidence of MACCE

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Guoliang Li

CONTACT

[email protected]

+86.29.85323869

Yang Yan

CONTACT

[email protected]

+86.29.85323869

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Collaborators

  • Qinghai People's Hospital
  • Second Affiliated Hospital of Nanchang University
  • Zhejiang Provincial People's Hospital

Registry information

Official study 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

Acronym: ADVANCED-XJ-Ⅱ

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 10, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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