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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Complication of Surgical Procedure; Aortic Diseases; Type A Aortic Dissection
• Intervention / Treatment: Procedure: Vascular Grafts Eversion and Built-in Technique(XJ-Procedure)

Detailed Description

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
• Enrollment (Estimated): 680
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yang Yan; Phone Number: +86.29.85323869; Email: yangyan3@xjtu.edu.cn
• Study Contact Backup: Name: Guoliang Li; Phone Number: +86.29.85323869; Email: liguoliang_med@163.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • First Affiliated Hospital of Xi'an JiaoTong University
      • Contact: Yang Yan; Phone Number: 0086-18991232621; Email: yangyan3@xjtu.edu.cn
      • Contact: Fengwei Guo; Phone Number: 0086-13991259800; Email: guofengwei@xjtu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XJ-Procedure Group; In the XJ-Procedure Group, Patients will be performed the standard "Sun's procedure" after general anesthesia, in which the end-to-end anastomosis between the artificial vessel and the aortic root is performed using the "Vascular Grafts Eversion and Built-in Technique" during the aortic root suture.	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.
No Intervention: Control Group; In the Control Group, Patients will be performed the standard "Sun's procedure" which involves aortic root anastomosis using the regular technique at each cardiovascular surgery center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	About 20 days (during hospitalization), at the 3 months,6 months, and 12 months follow-up

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: Zhejiang Provincial People's Hospital; Qinghai People's Hospital; Second Affiliated Hospital of Nanchang University
• Investigators: Principal Investigator: Guoliang Li, First Affiliated Hospital Xi'an Jiaotong University; Principal Investigator: Yang Yan, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: December 28, 2023
• First Posted (Actual): January 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Postoperative Complication; Cardiovascular Surgery; Type A Aortic Dissection; Aortic Root Reinforcement
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Dissection, Blood Vessel; Acute Aortic Syndrome; Aortic Diseases; Aortic Dissection
• Other Study ID Numbers: XJTU1AF2023LSYY-006-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No