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

Complication of Surgical Procedure Clinical Trial

— ADVANCED-XJ-?  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06199401
• Other study ID #: XJTU1AF-CRF-2023-XK006
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2024
• Est. completion date: December 1, 2027

Study information

• Verified date: April 2024
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yang Yan
• Phone: +86.29.85323869
• Email: yangyan3[@]xjtu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 680
• Est. completion date: December 1, 2027
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Diseases
• Aortic Dissection
• Complication of Surgical Procedure
• Type A Aortic Dissection

Intervention

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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (4)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Qinghai People's Hospital, Second Affiliated Hospital of Nanchang University, Zhejiang Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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