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 )

NCT ID: NCT05751200

Last Updated: 2023-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

183 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-03-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type A Aortic Dissection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No Intervention.

Intervention Type 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.

No Intervention.

Intervention Type OTHER

No Intervention.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No Intervention.

No Intervention.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yang Yan

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

Li J, Zhao C, Li B, Yan P, Zhang Y, Li Y, Wang Q, He X, Zheng X, Yan Y. Aortic Root Reinforcement Combined with Vascular Grafts Eversion and Built-in Procedure (XJ-Procedure) for Acute Type A Aortic Dissection Surgery. Adv Ther. 2023 Dec;40(12):5354-5365. doi: 10.1007/s12325-023-02655-2. Epub 2023 Oct 4.

Reference Type DERIVED
PMID: 37789228 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

XJTU1AF2023LSK-150

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Outcomes of Aortic Dissection Repair
NCT05927090 ENROLLING_BY_INVITATION