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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 )

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05751200
Enrollment
183
Registered
2023-03-02
Start date
2023-03-01
Completion date
2023-03-02
Last updated
2023-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type A Aortic Dissection

Keywords

Type A Aortic Dissection

Brief 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.

Detailed 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.

Interventions

OTHERNo Intervention.

No Intervention.

Sponsors

First Affiliated Hospital Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
30-day mortalityWithin 30 days after the surgeryPatients died within 30 days after the surgery. Data were obtained from the medical records.

Secondary

MeasureTime frameDescription
The postoperative bleeding necessitating re-operationAbout 2 weeks after the surgery.Postoperative bleeding necessitated reoperation during hospitalization. Data were obtained from the surgical records and medical records.
Change in the incidence of anastomotic pseudoaneurysmAbout 2 weeks after surgery, 3-month and 6-month follow-up.The occurrence of anastomotic pseudoaneurysm was examined by postoperative computed tomography angiography examination.
Change in the incidence of residual aortic root dissectionAbout 2 weeks after surgery, 3-month and 6-month follow-up.The occurrence of residual aortic dissection was examined by postoperative computed tomography angiography examination.
Change in the incidence of severe aortic regurgitationAbout 2 weeks after surgery, 3-month and 6-month follow-up.The occurrence of aortic valve regurgitation greater than grade2+, which was decided by cardiac ultrasonography.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026