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

NCT06199401 | Recruiting

• 1 other identifier: XJTU1AF2023LSYY-006-1
• Study Type: interventional
• Target: 680
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Type A Aortic Dissection; Aortic Root Reinforcement; Cardiovascular Surgery; Postoperative Complication

Outcome Measures

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.

  12 months follow-up

Secondary Outcomes (5)

• Change of incidence of residual aortic root dissection

  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

  About 20 days (during hospitalization)

• Change of incidence of anastomotic pseudoaneurysms during hospitalization

  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

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

• Change of incidence of MACCE

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

Study Arms (2)

XJ-Procedure Group

EXPERIMENTAL

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)

Control Group

NO INTERVENTION

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.

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.

XJ-Procedure Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years;
• Patients with ATAAD attending the relevant department who have been assessed by a clinician as needing "Sun's procedure".

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Zhejiang Provincial People's Hospital: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• Qinghai People's Hospital: collaborator

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Aortic Diseases; Postoperative Complications

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yang Yan

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

• Guoliang Li

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Yan

CONTACT

+86.29.85323869; yangyan3@xjtu.edu.cn

Guoliang Li

CONTACT

+86.29.85323869; liguoliang_med@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 10, 2024
• Study Start: January 11, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 12, 2024

Record last verified: 2024-04

Locations

CN (1)