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Completed

NCT Number: NCT05751200

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 )

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.

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Key information

Conditions

Type A Aortic Dissection

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention.

Other

No Intervention.

Primary outcomes

  1. 30-day mortality

    Time frame: Within 30 days after the surgery

    Patients died within 30 days after the surgery. Data were obtained from the medical records.

Secondary outcomes

  1. The postoperative bleeding necessitating re-operation

    Time frame: About 2 weeks after the surgery.

    Postoperative bleeding necessitated reoperation during hospitalization. Data were obtained from the surgical records and medical records.

  2. Change in the incidence of anastomotic pseudoaneurysm

    Time frame: About 2 weeks after surgery, 3-month and 6-month follow-up.

    The occurrence of anastomotic pseudoaneurysm was examined by postoperative computed tomography angiography examination.

  3. Change in the incidence of residual aortic root dissection

    Time frame: About 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.

  4. Change in the incidence of severe aortic regurgitation

    Time frame: About 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.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2023
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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