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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05751200
Other study ID # XJTU1AF2023LSK-150
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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