Safety and Efficacy of Aortic Root Reinforcement Combined With Vascular Grafts Eversion and built-in Procedure (XJ-procedure) in Patients With Acute Type A Aortic Dissection (ADVANCED-XJ )

Type A Aortic Dissection Clinical Trial

Official title:

Safety and Efficacy of Aortic Root Reinforcement Combined With Vascular Grafts Eversion and built-in Procedure (XJ-procedure) in Patients With Acute Type A Aortic Dissection (ADVANCED-XJ ): an Investigator-initiated, Single-center, Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05751200
• Other study ID #: XJTU1AF2023LSK-150
• Status: Completed
• Start date: March 1, 2023
• Est. completion date: March 2, 2023

Study information

• Verified date: August 2023
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a retrospective study based on the data available in our hospital database for ATAAD patients from January 2020 to December 2021. These patients were divided into two groups according to the surgical procedures of aortic root. This study compared baseline data, perioperative and short-term follow-up results between the two groups to evaluate the efficacy and safety of XJ-procedure in ATAAD.

Description:

Acute type A aortic dissection (ATAAD) is a life-threatening disease with high mortality. Surgery remains the gold standard for the treatment of ATAAD. In recent years, ATAAD is still a persistent challenge for cardiovascular surgeons. This is a retrospective study based on the data available in our hospital database for ATAAD patients undergoing total aortic arch replacement with elephant trunk stent under cryogenic stop circulation from January 2020 to December 2021. These patients were divided into two groups according to the surgical procedures of aortic root: continuous aortic root suture group (CARS group); "aortic root reinforcement combined with vascular grafts eversion and built-in", which was created by our group and to be named as XJ-procedure (XJ-procedure group, XJ is an acronym for Xi'an Jiaotong University). The main outcome was defined as 30-day mortality. Secondary outcomes included the postoperative bleeding necessitating re-operation and the incidence of anastomotic pseudoaneurysm, residual aortic root dissection and severe aortic regurgitation before discharge and at 3 and 6 months after the operation. This study compared baseline data, perioperative and short-term follow-up results between the two groups to evaluate the efficacy and safety of XJ-procedure in ATAAD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: March 2, 2023
• Est. primary completion date: March 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosed with ATAAD by computed tomography angiography (CTA) from January 2020 to December 2021 in the First Affiliated Hospital of Xi'an Jiaotong University

• Mild to moderate aortic root involvement

• Aortic arch involvement undergoing Sun's procedure

Exclusion Criteria:

• Patients with severe aortic root involvement (root diameter >45 mm, root tear, severe disruption of aortic root, concomitant valve disease)

• The Bentall, Wheat or David procedure performed

• Recurrent ATAAD

• Preoperative severe brain complications (cerebral infarction, cerebral hemorrhage, coma, etc.)

• Mal-perfusion of abdominal organs or lower extremities >12 h

• Incomplete clinical data.

Related Conditions & MeSH terms

• Aortic Dissection
• Type A Aortic Dissection

Intervention

Other:
• No Intervention.
No Intervention.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality	Patients died within 30 days after the surgery. Data were obtained from the medical records.	Within 30 days after the surgery
Secondary	The postoperative bleeding necessitating re-operation	Postoperative bleeding necessitated reoperation during hospitalization. Data were obtained from the surgical records and medical records.	About 2 weeks after the surgery.
Secondary	Change in the incidence of anastomotic pseudoaneurysm	The occurrence of anastomotic pseudoaneurysm was examined by postoperative computed tomography angiography examination.	About 2 weeks after surgery, 3-month and 6-month follow-up.
Secondary	Change in the incidence of residual aortic root dissection	The occurrence of residual aortic dissection was examined by postoperative computed tomography angiography examination.	About 2 weeks after surgery, 3-month and 6-month follow-up.
Secondary	Change in the incidence of severe aortic regurgitation	The occurrence of aortic valve regurgitation greater than grade2+, which was decided by cardiac ultrasonography.	About 2 weeks after surgery, 3-month and 6-month follow-up.