CClinicalTrials.gg
CompletedNCT05751200Updated Aug 9, 2023

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 observational study in Type A Aortic Dissection, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2023-08-09.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
183
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type A Aortic Dissection

Browse trials for

Keywords

  • Type A Aortic Dissection
03

In context

Aortic Dissection

386 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.

This study's enrollment of 183 is close to the median of 183 across 180 observational studies indexed under Aortic Dissection.

Browse Aortic Dissection studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study enrolled patients who were diagnosed with ATAAD by computed tomography angiography (CTA) from January 2020 to December 2021 in the First Affiliated Hospital of Xi'an Jiaotong University. Inclusion criteria included mild to moderate aortic root involvement, combined with aortic arch involvement undergoing Sun's procedure. The exclusion criteria included 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 and incomplete clinical data.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
183 participants (actual)
Patient registry
No

Groups and cohorts

  • CARS group

    In the CARS group, 3-0 polypropylene was used to suture the proximal end of aortic with the vascular grafts continuously, followed by one interrupted suture loop of 3-0 polypropylene for reinforcement.

    Other: No Intervention.

  • XJ-procedure group

    In the XJ-procedure group, a 1.5-2cm wide bovine pericardial patch and graft ring were 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 was intermittently sutured to full layers of aortic vascular with 2-0 pad polyester sutures. Finally, the eversion and aortic wall were continuously sutured together in one more turn.

    Other: No Intervention.

Interventions

  • OtherNo Intervention.

    No Intervention.

06

What researchers measure

Primary outcomes

  1. 30-day mortality

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

    Time frame: Within 30 days after the surgery

Secondary outcomes

  1. The postoperative bleeding necessitating re-operation

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

    Time frame: About 2 weeks after the surgery.

  2. Change in the incidence of anastomotic pseudoaneurysm

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

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

  3. Change in the incidence of residual aortic root dissection

    The occurrence of residual aortic dissection was examined by postoperative computed tomography angiography examination.

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

  4. Change in the incidence of severe aortic regurgitation

    The occurrence of aortic valve regurgitation greater than grade2+, which was decided by cardiac ultrasonography.

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

07

Study locations

1 site
  • The First Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, Shaanxi 710061, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05751200
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Responsible party
Sponsor
First posted
Mar 2, 2023
Start date
Mar 1, 2023
Primary completion
Mar 2, 2023
Completion
Mar 2, 2023
Last update
Aug 9, 2023

Study contacts

Yang Yan
principal investigator · First Affiliated Hospital Xi'an Jiaotong University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion